Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
Phase 2
Completed
- Conditions
- Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors
- Registration Number
- NCT00108758
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).
The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
Inclusion Criteria
- Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively
Exclusion Criteria
- Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction of bleeds During 3 months treatment period as compared to 3 months observation period
- Secondary Outcome Measures
Name Time Method Efficacy variables
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇷Capa-ISTANBUL, Turkey
Novo Nordisk Investigational Site🇹🇷Capa-ISTANBUL, Turkey