Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

• Status: Active, not recruiting
• Trial end date: 2023-06-17
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

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