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

Completed

• Conditions: Congenital Bleeding Disorder; Congenital FVII Deficiency; Glanzmann's Disease; Acquired Bleeding Disorder; Acquired Haemophilia
• Interventions: Drug: eptacog alfa (activated)

• Registration Number: NCT00697320
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	eptacog alfa (activated)	-

Primary Outcome Measures

Name	Time	Method
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®

Secondary Outcome Measures

Name	Time	Method
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)
Time proportion of acute bleeding treatments resulting in effective pain relief	within 9 hours after initiation of treatment with NovoSeven®

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Mainz, Germany