Trials / Completed
CompletedNCT01386268
Kogenate FS Regulatory Post-Marketing Surveillance
KOGENATE® FS , Local Post Authorization Safety Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 64 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2013-01-01
- Completion
- 2013-08-01
- First posted
- 2011-07-01
- Last updated
- 2014-08-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01386268. Inclusion in this directory is not an endorsement.