Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
NCT02938585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2020-07-27
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%).
Conditions
- Congenital Bleeding Disorder
- Haemophilia A
Interventions
- DRUG
-
turoctocog alfa
The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
- DRUG
-
turoctocog alfa
Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-12
- Primary Completion
- 2018-03-16
- Completion
- 2018-12-12
Countries
- China
Study Locations
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