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

Novo Nordisk A/S21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acquired Bleeding Disorder Acquired Haemophilia

Interventions

activated recombinant human factor VIIDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Paris La Défense Cedex, France

Outcomes

Primary Outcomes

Identification of decision criteria to treat patient with activated recombinant human factor VII

Time frame: Year 3

Secondary Outcomes

Number of patients with a control of bleeding

Time frame: Year 3

Data from ClinicalTrials.gov

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