Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
Completed
- Conditions
- Acquired Bleeding DisorderAcquired Haemophilia
- Interventions
- Drug: activated recombinant human factor VII
- Registration Number
- NCT01285089
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Diagnosed with acquired haemophilia
- Treated with activated recombinant human factor VII as first line treatment
- Treated with activated recombinant human factor VII after January 2011
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Exclusion Criteria
- Patients with first diagnosis before january 2010 and having a relapse after january 2011
- Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
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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 Identification of decision criteria to treat patient with activated recombinant human factor VII Year 3
- Secondary Outcome Measures
Name Time Method Number of patients with a control of bleeding Year 3