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Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany (WIRK)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00697320
First received: June 11, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.


Condition Intervention
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Acquired Bleeding Disorder
Acquired Haemophilia
Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy of NovoSeven® (Activated Recombinant Human Factor VII): Non-interventional Study in Patients With Congenital Haemophilia With Inhibitors, Acquired Haemophilia, Factor FVII Deficiency, and Glanzmann's Thrombasthenia

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven® ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time proportion of acute bleeding treatments resulting in effective pain relief [ Time Frame: within 9 hours after initiation of treatment with NovoSeven® ] [ Designated as safety issue: Yes ]
  • Proportion of patients experiencing one or more re-bleeds [ Time Frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding) ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: activated recombinant human factor VII

A NON INTERVENTIONAL OBSERVATIONAL STUDY:

Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Other Names:
  • NovoSeven®
  • F7

  Eligibility

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

Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®.

Criteria

Inclusion Criteria:

  • Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication

Exclusion Criteria:

  • Due to the non-interventional observational character of the study, there are no exclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697320

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Lampen, PhD Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00697320     History of Changes
Other Study ID Numbers: F7HAEM-1921
Study First Received: June 11, 2008
Last Updated: August 8, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Disease
Hemorrhage
Hemorrhagic Disorders
Thrombasthenia
Blood Platelet Disorders
Cardiovascular Diseases
Genetic Diseases, Inborn
Hematologic Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014