Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

• Status: Completed
• Trial end date: 2018-12-05
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.

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

Details

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

Criteria

Inclusion Criteria:

• Age below 6 years

• Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)

• Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)

• No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®

Exclusion Criteria:

• Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products

• Previous participation in this trial defined as withdrawal after administration of trial product

• Congenital or acquired coagulation disorders other than haemophilia A

• Any history of Factor VIII inhibitor

• Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)