Acquired Bleeding Disorder Clinical Trial
— ACQUI-7Official title:
Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of decision criteria to treat patient with activated recombinant human factor VII | Year 3 | No | |
Secondary | Number of patients with a control of bleeding | Year 3 | No |
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