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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:
ClinicalTrials.gov Identifier:
NCT00697320
First Posted: June 13, 2008
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: eptacog alfa (activated)

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® ]

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® ]
  • 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) ]

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: eptacog alfa (activated)

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
  • activated recombinant human factor VII

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697320


Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00697320     History of Changes
Other Study ID Numbers: F7HAEM-1921
First Submitted: June 11, 2008
First Posted: June 13, 2008
Last Update Posted: December 7, 2016
Last Verified: December 2016

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