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Completed

NCT Number: NCT01285089

Observational Study on the Use of NovoSeven® for 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.

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Key information

Conditions

Acquired Bleeding Disorder Acquired Haemophilia

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris La Défense Cedex, 92932, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

Primary outcomes

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

    Time frame: Year 3

Secondary outcomes

  1. Number of patients with a control of bleeding

    Time frame: Year 3

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: ACQUI-7

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2011
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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