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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01285089

Acronym

ACQUI-7

Enrollment

Registered

2011-01-27

Start date

2010-12-31

Completion date

2013-10-31

Last updated

2014-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Acquired Haemophilia

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.

Interventions

DRUGactivated recombinant human factor VII

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Identification of decision criteria to treat patient with activated recombinant human factor VII	Year 3

Secondary

Measure	Time frame
Number of patients with a control of bleeding	Year 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026