Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia (ACQUI-7)

Novo Nordisk

Status: Completed

Conditions: Acquired Haemophilia; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Observational

Funder types: Industry

Identifiers

NCT01285089

F7HAEM-3856

U1111-1114-8926 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII