Study Investigating Novoeight®/NovoEight® (Turoctocog Alf... | NCT03179748

Studies
Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

NCT03179748

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Nov 15, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Congenital Bleeding Disorder
Haemophilia A

Interventions

turoctocog alfa

Countries

Mexico

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1171-9845	Other Identifier	World Health Organization (WHO)

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

Start Date

Jun 20, 2018Actual

Primary Completion Date

Jun 16, 2021Actual

Completion Date

Jun 16, 2021Actual

First Submitted Date

May 24, 2017

First Submission Date that Met QC Criteria

Jun 6, 2017

First Posted Date

Jun 7, 2017Actual

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

Nov 12, 2021

Last Update Posted Date

Nov 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
turoctocog alfa		Patients with haemophilia A	Drug: turoctocog alfa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
turoctocog alfa	Drug	Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician	turoctocog alfa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of adverse reactions	Count and % of events	3-36 months after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Frequency of adverse events	Count and % of events	3-36 months after enrollment
Efficacy in treatment of bleeds	Rated: Excellent, Good, Moderate or none

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
Male and female patients with haemophilia A
Age range is 0 years and above
The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

Exclusion Criteria:

Previous participation in this study. Participation is defined as having given informed consent in this study
Known or suspected allergy to turoctocog alfa or related products
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population are haemophilia A patients who based on the indication will benefit from treatment with turoctocog alfa. No limitation has been set to the severity of haemophilia A, gender, age, previously treated and untreated patients.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Monterrey	Nuevo León	64460	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Condition 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

Browse Leaves

Not provided

Browse Branches

Not provided