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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01285089
First received: January 26, 2011
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Acquired Bleeding Disorder
Acquired Haemophilia
 Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Identification of decision criteria to treat patient with activated recombinant human factor VII [ Time Frame: Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with a control of bleeding [ Time Frame: Year 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: activated recombinant human factor VII
Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient diagnosed with acquired haemophilia and treated with at least one injection of activated recombinant human factor VII can be included in the study. The treatment will be performed according the local practice.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285089

Locations
France
Paris La défense cedex, France, 92932
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Françoise TRUONG Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01285089     History of Changes
Other Study ID Numbers: F7HAEM-3856, U1111-1114-8926
Study First Received: January 26, 2011
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
 Hemophilia A
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013