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

Novo Nordisk

Status: Completed

Conditions: Acquired Haemophilia; Glanzmann's Disease; Congenital Bleeding Disorder; Acquired Bleeding Disorder; Congenital FVII Deficiency

Treatments: Drug: eptacog alfa (activated)

Study type: Observational

Funder types: Industry

Identifiers

NCT00697320

F7HAEM-1921

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

64 participants in 1 patient group

A

Treatment:

Drug: eptacog alfa (activated)