Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

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

Summary

This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).

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

Details

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

Criteria

Inclusion Criteria:

• Male patients

• Age from 0 years

• With the diagnosis of severe congenital haemophilia A (FVIII≤1%)

• History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:

• Patients of 12 years or above: 100 exposures days (ED) or more

• Patients below 12 years: 50 exposure days (ED) or more

Exclusion Criteria:

• Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory

• Known history of FVIII inhibitors