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

Congenital Bleeding Disorder Clinical Trial

— WIRK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697320
• Other study ID #: F7HAEM-1921
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: December 6, 2016
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Acquired Haemophilia
• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Congenital FVII Deficiency
• Disease
• Glanzmann's Disease
• Hemophilia A
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved		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®	No
Secondary	Time proportion of acute bleeding treatments resulting in effective pain relief		within 9 hours after initiation of treatment with NovoSeven®	Yes
Secondary	Proportion of patients experiencing one or more re-bleeds		within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)	Yes

External Links

•   Clinical Trials at Novo Nordisk