Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
Completed
- Conditions
- Congenital Bleeding DisorderHaemophilia AHaemophilia B
- Interventions
- Drug: activated recombinant human factor VII
- Registration Number
- NCT00853086
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.
- Detailed Description
Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 139
Inclusion Criteria
- All haemophilia A or B patients with inhibitors treated with NovoSeven are included
Exclusion Criteria
- No exclusion criteria beyond the contraindications described in the approved product information text
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A activated recombinant human factor VII -
- Primary Outcome Measures
Name Time Method Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes. Assessments at 6 month intervals
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Crawley, United Kingdom