Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Bleeding Disorder Acquired Haemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

activated recombinant human factor VII

Intervention Type DRUG

Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices

Interventions

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activated recombinant human factor VII

Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No