Brief Title
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
Official Title
An Open-label Single-arm Multicentre Non-controlled Phase 3a Trial Investigating Safety and Efficacy of N8-GP in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Paediatric Patients With Severe Haemophilia A
Brief Summary
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of inhibitory antibodies against coagulation factor VIII (FVIII)
Secondary Outcome
Frequency of adverse events including serious adverse events and medical events of special interest
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa pegol
Study Arms / Comparison Groups
50 EDs (exposure days)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
125
Start Date
June 26, 2014
Completion Date
June 17, 2023
Primary Completion Date
June 17, 2023
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 suitability for the trial - Male, age below 6 years of age at the time of signing informed consent - Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results - No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable) Exclusion Criteria: - Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products - Previous participation in this trial. Participation is defined as first dose administered of trial product - Receipt of any investigational medicinal product within 30 days before screening - Congenital or acquired coagulation disorder other than haemophilia A - Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol - Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
Gender
Male
Ages
N/A - 6 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Algeria
Location Countries
Algeria
Administrative Informations
NCT ID
NCT02137850
Organization ID
NN7088-3908
Secondary IDs
2013-004025-88
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
March 2022