Trials / Completed
CompletedNCT00697320
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 64 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Congenital Bleeding Disorder
- Congenital FVII Deficiency
- Glanzmann's Disease
- Acquired Bleeding Disorder
- Acquired Haemophilia
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-06-13
- Last updated
- 2016-12-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00697320. Inclusion in this directory is not an endorsement.