Trial Investigating Safety, Pharmacokinetics and Pharmaco... | NCT02490787

Studies
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

NCT02490787

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Congenital Bleeding Disorder
Haemophilia A

Interventions

Concizumab
placebo

Countries

United States
Australia
Austria
Croatia
France
Germany
Israel
Malaysia
Netherlands
Poland
Spain
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description
2014-003793-16	EudraCT Number
U1111-1161-1501	Other Identifier	WHO
NL53826.018.15	Registry Identifier	Netherlands Registry

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2015Actual

Primary Completion Date

Oct 14, 2016Actual

Completion Date

Oct 14, 2016Actual

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2017

Last Update Posted Date

Jul 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

Detailed Description

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concizumab	Experimental		Drug: Concizumab Drug: placebo
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Concizumab	Drug	Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)	Concizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events (AEs)		From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary Outcomes

Measure	Description	Time Frame
Trough level of concizumab		Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies		From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
Age between 18 and 64 years both inclusive, at the time of signing informed consent
Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

Known or suspected hypersensitivity to trial product or related products
Platelet count below 50x10^9/L at screening
Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
Subjects at increased risk of cardiovascular disease as judged by the investigator

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Torrance	California	90502-2004	United States
Novo Nordisk Investigational Site

Label	URL
Clinical Trials at Novo Nordisk	View source

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

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020147	Coagulation Protein Disorders
D006474	Hemorrhagic Disorders
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities