A Trial Evaluating Efficacy and Safety of Prophylactic Ad... | NCT03196297 | Trialant
NCT03196297
Sponsor
Novo Nordisk A/S
Status
Completed
Last Update Posted
Nov 16, 2021Actual
Enrollment
36Actual
Phase
Phase 2
Conditions
Haemostasis
Haemophilia A
Interventions
Concizumab
Turoctocog alfa
Countries
United States
France
Germany
Italy
Japan
Spain
Sweden
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03196297
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN7415-4255
Secondary IDs
ID
Type
Description
Link
U1111-1179-3872
Other Identifier
World Health Organization (WHO)
2016-000614-29
Registry Identifier
EudraCT
JapicCTI-173682
Registry Identifier
JAPIC
Brief Title
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Official Title
A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Acronym
explorerâ„¢5
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Nov 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 16, 2017Actual
Primary Completion Date
Jun 22, 2018Actual
Completion Date
Jun 3, 2020Actual
First Submitted Date
Jun 20, 2017
First Submission Date that Met QC Criteria
Jun 20, 2017
First Posted Date
Jun 22, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Apr 14, 2021
Results First Submitted that Met QC Criteria
Apr 14, 2021
Results First Posted Date
May 10, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 4, 2019
Certification/Extension First Submitted that Passed QC Review
Sep 4, 2019
Certification/Extension First Posted Date
Sep 11, 2019Actual
Last Update Submitted Date
Nov 15, 2021
Last Update Posted Date
Nov 16, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.
Detailed Description
Not provided
Conditions Module
Conditions
Haemostasis
Haemophilia A
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
36Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Concizumab
Experimental
Daily administration of concizumab to both on-demand and prophylaxis patients
Drug: Concizumab
Drug: Turoctocog alfa
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Concizumab
Drug
0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
During at least 24 weeks from treatment onset
Secondary Outcomes
Measure
Description
Time Frame
The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
During at least 76 weeks from treatment onset
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The trial consisted of two treatment periods: main part which lasted at least 24 weeks for all participants in the trial and an extension part which was up to 102 weeks.
Recruitment Details
The trial was conducted at 26 sites in 11 countries as follows: France (3), Germany (2), Italy (1), Japan (3), Spain (3), Sweden (2), Thailand (1), Turkey (3), the United Kingdom (4), Ukraine (1) and the United States (3). In addition to these sites, 5 sites were approved by the IRB/IEC and/or local health authority but did not screen or assign any participants to treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Concizumab
Participants received subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (at least 24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes.
Periods
Title
Milestones
Reasons Not Completed
Main Period
Type
Comment
Milestone Data
STARTED
Concizumab- Main part
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 28, 2018
Apr 14, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Concizumab
Turoctocog alfa
Drug
Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels
Concizumab
The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
During at least 24 weeks from treatment onset
The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
During at least 76 weeks from treatment onset
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
During at least 24 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
During at least 76 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
During at least 24 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
During at least 76 weeks from treatment onset (week 0)
Change in Fibrinogen During 24 Weeks From Treatment Onset
Change in fibrinogen during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in Fibrinogen During at Least 76 Weeks From Treatment Onset
Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Change in D-dimer During 24 Weeks From Treatment Onset
Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in D-dimer During at Least 76 Weeks From Treatment Onset
Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During 24 Weeks From Treatment Onset
Change in F1 + F2 during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During at Least 76 Weeks From Treatment Onset
Change in F1 + F2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT) During 24 Weeks From Treatment Onset
Change in PT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT) During at Least 76 Weeks From Treatment Onset
Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT) During 24 Weeks From Treatment Onset
Change in APTT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT) During at Least 76 Weeks From Treatment Onset
Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT) During 24 Weeks From Treatment Onset
Change in AT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During 24 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT) After at Least 76 Weeks From Treatment
Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
During at least 76 weeks from treatment onset (week 0)
Concentration of Concizumab Prior to the Last Dose Administration at 24 Weeks
Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration at 24 weeks
Concentration of Concizumab Prior to the Last Dose Administration After at Least 76 Weeks
Concentration of concizumab prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration after at least 76 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration at 24 Weeks
Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration at 24 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration After at Least 76 Weeks
Free TFPI concentration value prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration after at least 76 weeks
Peak Thrombin Generation Prior to the Last Dose Administration at 24 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration at 24 weeks
Peak Thrombin Generation Prior to the Last Dose Administration After at Least 76 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration after at least 76 weeks
Endogenous Thrombin Potential Prior to the Last Dose Administration at 24 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration at 24 weeks
Endogenous Thrombin Potential Prior to the Last Dose Administration After at Least 76 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration after at least 76 weeks
Thrombin Generation Velocity Index Prior to the Last Dose Administration at 24 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration at 24 weeks
Thrombin Generation Velocity Index Prior to the Last Dose Administration After at Least 76 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Prior to the last dose administration after at least 76 weeks
Indianapolis
Indiana
46260
United States
Novo Nordisk Investigational Site
Oklahoma City
Oklahoma
73104
United States
Novo Nordisk Investigational Site
Nashville
Tennessee
37232
United States
Novo Nordisk Investigational Site
Salt Lake City
Utah
84113
United States
Novo Nordisk Investigational Site
Brest
29609
France
Novo Nordisk Investigational Site
Caen
14033
France
Novo Nordisk Investigational Site
Nantes
44093
France
Novo Nordisk Investigational Site
Bonn
53127
Germany
Novo Nordisk Investigational Site
Homburg
66421
Germany
Novo Nordisk Investigational Site
Milan
20124
Italy
Novo Nordisk Investigational Site
Rome
00168
Italy
Novo Nordisk Investigational Site
Aichi
466-8560
Japan
Novo Nordisk Investigational Site
Nara
634-8522
Japan
Novo Nordisk Investigational Site
Tokyo
160-0023
Japan
Novo Nordisk Investigational Site
Tokyo
167-0035
Japan
Novo Nordisk Investigational Site
Madrid
28046
Spain
Novo Nordisk Investigational Site
Málaga
29010
Spain
Novo Nordisk Investigational Site
Valencia
46026
Spain
Novo Nordisk Investigational Site
Malmö
205 02
Sweden
Novo Nordisk Investigational Site
Solna
171 64
Sweden
Novo Nordisk Investigational Site
Bangkok
10400
Thailand
Novo Nordisk Investigational Site
Ankara
06100
Turkey (Türkiye)
Novo Nordisk Investigational Site
Bornova-IZMIR
35100
Turkey (Türkiye)
Novo Nordisk Investigational Site
Edirne
22030
Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul
34098
Turkey (Türkiye)
Novo Nordisk Investigational Site
Lviv
79044
Ukraine
Novo Nordisk Investigational Site
Belfast
BT9 7AB
United Kingdom
Novo Nordisk Investigational Site
Cambridge
CB2 0QQ
United Kingdom
Novo Nordisk Investigational Site
London
NW3 2QG
United Kingdom
Novo Nordisk Investigational Site
London
SE1 7EH
United Kingdom
Derived
Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.
FG00036 subjects
Full Analysis Set (FAS)
FG00036 subjects
Subject Analysis Set (SAS)
FG00036 subjects
COMPLETED
FG00032 subjects
NOT COMPLETED
FG0004 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0004 subjects
Extension Period
Type
Comment
Milestone Data
STARTED
FG00032 subjects
FAS
FG00032 subjects
SAS
FG00032 subjects
COMPLETED
FG00029 subjects
NOT COMPLETED
FG0003 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
Lack of Efficacy
FG0002 subjects
Full analysis set (FAS) included all dosed participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Concizumab
Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for up to 126 weeks (24 weeks main part + 52-102 weeks extension part). The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants continued the extension phase at the same dose of concizumab once daily they have reached at the end of main part for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Denominators
Units
Counts
Participants
BG00036
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00036.9± 12.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
Male
BG00036
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
Not Hispanic or Latino
BG00030
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0008
White
BG00024
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
The FAS included all participants who took al least one dose of the study drug.
Posted
Number
Episodes
During at least 24 weeks from treatment onset
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00021
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG00043
OG00113
OG00214
Secondary
The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
The FAS included all participants who took al least one dose of the study drug.
Posted
Number
Episodes
During at least 76 weeks from treatment onset
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
The FAS included all participants who took al least one dose of the study drug.
Posted
Number
Episodes
During at least 24 weeks from treatment onset
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
The FAS included all participants who took al least one dose of the study drug.
Posted
Number
Episodes
During at least 76 weeks from treatment onset
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
The SAS included all participants who took al least one dose of the study drug.
Posted
Number
Events
During at least 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
The SAS included all participants who took al least one dose of the study drug.
Posted
Number
Events
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
The FAS included all participants who took al least one dose of the study drug.
Posted
Count of Participants
Participants
During at least 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab - Main Part
Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG000
Secondary
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
The FAS included all participants who took al least one dose of the study drug.
Posted
Count of Participants
Participants
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab
Participants who completed main part treatment were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG000
Secondary
Change in Fibrinogen During 24 Weeks From Treatment Onset
Change in fibrinogen during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
gram per litre (g/L)
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in Fibrinogen During at Least 76 Weeks From Treatment Onset
Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
gram per litre (g/L)
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Change in D-dimer During 24 Weeks From Treatment Onset
Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Nanograms per milliliter (ng/mL)
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in D-dimer During at Least 76 Weeks From Treatment Onset
Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Nanograms per milliliter (ng/mL)
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During 24 Weeks From Treatment Onset
Change in F1 + F2 during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Picomoles per liter (pmol/L)
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During at Least 76 Weeks From Treatment Onset
Change in F1 + F2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
pmol/L
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Change in Prothrombin Time (PT) During 24 Weeks From Treatment Onset
Change in PT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Seconds (sec)
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in Prothrombin Time (PT) During at Least 76 Weeks From Treatment Onset
Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
sec
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Change in Activated Partial Thromboplastin Time (APTT) During 24 Weeks From Treatment Onset
Change in APTT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
sec
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in Activated Partial Thromboplastin Time (APTT) During at Least 76 Weeks From Treatment Onset
Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
sec
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Change in Anti-thrombin (AT) During 24 Weeks From Treatment Onset
Change in AT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Percentage point
During 24 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Change in Anti-thrombin (AT) After at Least 76 Weeks From Treatment
Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The SAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
second
During at least 76 weeks from treatment onset (week 0)
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Concentration of Concizumab Prior to the Last Dose Administration at 24 Weeks
Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
ng/mL
Prior to the last dose administration at 24 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Concentration of Concizumab Prior to the Last Dose Administration After at Least 76 Weeks
Concentration of concizumab prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
ng/mL
Prior to the last dose administration after at least 76 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration at 24 Weeks
Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
ng/mL
Prior to the last dose administration at 24 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Concizumab 0.25 mg/kg- Main Part
Secondary
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration After at Least 76 Weeks
Free TFPI concentration value prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
ng/mL
Prior to the last dose administration after at least 76 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Peak Thrombin Generation Prior to the Last Dose Administration at 24 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Nanomoles per liter (nmol/L)
Prior to the last dose administration at 24 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Secondary
Peak Thrombin Generation Prior to the Last Dose Administration After at Least 76 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
nmol/L
Prior to the last dose administration after at least 76 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Endogenous Thrombin Potential Prior to the Last Dose Administration at 24 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Nanomolar*minute (nM*min)
Prior to the last dose administration at 24 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Endogenous Thrombin Potential Prior to the Last Dose Administration After at Least 76 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
nM*min
Prior to the last dose administration after at least 76 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Secondary
Thrombin Generation Velocity Index Prior to the Last Dose Administration at 24 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
nM/min
Prior to the last dose administration at 24 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg- Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG002
Secondary
Thrombin Generation Velocity Index Prior to the Last Dose Administration After at Least 76 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
The FAS included all participants who took al least one dose of the study drug. Overall number of participants analysed = number of participants with available data at the last dose level.
Posted
Mean
Standard Deviation
Nano molar/min (nM/min)
Prior to the last dose administration after at least 76 weeks
ID
Title
Description
OG000
Concizumab 0.15 mg/kg
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
OG001
Concizumab 0.20 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Time Frame
From start of study drug administration (week 0) up to 134 weeks
Description
Results are based on the safety analysis set which included all dosed participants.
All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. The data is presented per dose level participants were on at the time of onset of the adverse event.
MedDRA version 21.0 is used for the main phase and MedDRA version 22.1 is used for the extension phase.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Concizumab 0.15 mg/kg - Main Part
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
36
0
36
26
36
EG001
Concizumab 0.20 mg/kg - Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
15
0
15
7
15
EG002
Concizumab 0.25 mg/kg - Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
8
0
8
3
8
EG003
Concizumab 0.15 mg/kg - Extension Part
Participants were to receive s.c. injection of 0.15 mg/kg of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks with the potential dose escalation based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
19
2
19
16
19
EG004
Concizumab 0.20 mg/kg - Extension Part
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
14
1
14
9
14
EG005
Concizumab 0.25 mg/kg - Extension Part
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
0
10
2
10
7
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atypical pneumonia
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected19 at risk
EG0040 events0 affected14 at risk
EG0051 events1 affected10 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected19 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected10 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected8 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Antithrombin III decreased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected8 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0004 events4 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Basophil count increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Crystalluria
Renal and urinary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Device physical property issue
Product Issues
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA 22
Systematic Assessment
EG0004 events3 affected36 at risk
EG0012 events2 affected15 at risk
EG0022 events2 affected8 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Granuloma
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0002 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected8 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Haemophilic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0007 events7 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 22
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Injection site bruising
General disorders
MedDRA 22
Systematic Assessment
EG0008 events5 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Injection site haematoma
General disorders
MedDRA 22
Systematic Assessment
EG0005 events4 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 22
Systematic Assessment
EG0006 events3 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Injection site induration
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Injection site pruritus
General disorders
MedDRA 22
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Lip discolouration
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0002 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG00011 events9 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Pinguecula
Eye disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Prothrombin fragment 1.2 increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Prothrombin level increased
Investigations
MedDRA 22
Systematic Assessment
EG0004 events3 affected36 at risk
EG0012 events2 affected15 at risk
EG0023 events2 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Pyoderma
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Soluble fibrin monomer complex increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Thrombin-antithrombin III complex increased
Investigations
MedDRA 22
Systematic Assessment
EG0003 events2 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Tooth repair
Surgical and medical procedures
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C574488
concizumab
C577506
recombinant factor VIII N8
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Unknown or Not Reported
BG0003
Other
BG0001
Not applicable
BG0003
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00015
OG00110
OG00210
Title
Denominators
Categories
Title
Measurements
OG00067
OG00142
OG002123
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00021
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG00016
OG0018
OG0022
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00015
OG00110
OG00210
Title
Denominators
Categories
Title
Measurements
OG00039
OG00115
OG00229
OG002
Concizumab 0.25 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00036
OG00115
OG0028
Title
Denominators
Categories
Title
Measurements
OG000105
OG00116
OG0029
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00036
OG00121
OG00211
Title
Denominators
Categories
Title
Measurements
OG000201
OG00153
OG00244
36
Title
Denominators
Categories
Title
Measurements
Yes
OG0003
No
OG00033
36
Title
Denominators
Categories
Title
Measurements
Yes
OG0009
No
OG00027
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG000-0.08± 0.61
OG001-0.19± 0.47
OG002-0.27± 0.29
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00013
OG00110
OG0027
Title
Denominators
Categories
Title
Measurements
OG000-0.05± 0.39
OG001-0.35± 0.56
OG002-0.23± 0.63
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG000184.5± 404.5
OG001272.9± 684.4
OG002703.8± 693.6
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00014
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG000265.4± 405.3
OG001506.7± 369.9
OG0021109.3± 818.5
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG000134± 156
OG001257± 524
OG002580± 741
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00014
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG000128± 183
OG001211± 207
OG002889± 423
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG000-0.0± 0.4
OG001-0.3± 0.9
OG0020.3± 0.7
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00014
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.4
OG0010.8± 2.7
OG0020.4± 0.4
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG0001.5± 10.2
OG0013.1± 6.1
OG0026.5± 6.9
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00014
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG0003.1± 4.3
OG0019.2± 8.8
OG0022.1± 9.4
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00019
OG0017
OG0028
Title
Denominators
Categories
Title
Measurements
OG0007± 13
OG00117± 31
OG0027± 18
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00014
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG0000± 12
OG00111± 23
OG00215± 25
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00018
OG0014
OG0026
Title
Denominators
Categories
Title
Measurements
OG000195.2± 147.0
OG001374.4± 644.0
OG0022640.8± 4085.6
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00013
OG00110
OG0027
Title
Denominators
Categories
Title
Measurements
OG000195.1± 161.7
OG001392.3± 427.9
OG0024015.1± 2902.0
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00018
OG0014
OG0026
Title
Denominators
Categories
Title
Measurements
OG00030.1± 15.6
OG00164.4± 35.3
OG00212.4± 2.2
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00013
OG00110
OG0027
Title
Denominators
Categories
Title
Measurements
OG00026.9± 17.1
OG00136.1± 33.1
OG00210.1± 5.7
Concizumab 0.25 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00018
OG0014
OG0025
Title
Denominators
Categories
Title
Measurements
OG00088.6± 34.5
OG00167.5± 35.0
OG00283.4± 10.6
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00013
OG00110
OG0027
Title
Denominators
Categories
Title
Measurements
OG00090.8± 45.2
OG00199.1± 36.2
OG002111.6± 63.5
OG002
Concizumab 0.25 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00018
OG0014
OG0025
Title
Denominators
Categories
Title
Measurements
OG0001229.1± 340.6
OG001965.3± 362.0
OG0021176.0± 278.8
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00013
OG00110
OG0027
Title
Denominators
Categories
Title
Measurements
OG0001253.0± 507.3
OG0011352.6± 349.5
OG0021233.4± 267.9
Concizumab 0.25 mg/kg- Main Part
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.
Units
Counts
Participants
OG00018
OG0014
OG0025
Title
Denominators
Categories
Title
Measurements
OG0009.3± 4.8
OG0017.0± 5.0
OG0028.2± 1.6
OG002
Concizumab 0.25 mg/kg
Participants were to receive s.c. injection of concizumab once daily. Participants who completed the main part (24 weeks) of the study were continued the same dose regimen for concizumab once daily for 52-102 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes. Breakthrough bleeding episodes occurring to the participants during the trial were treated with turoctocog at home.