Trials / Completed
CompletedNCT00606060
BAY14-2222 Continuous Infusion in Surgeries
Safety and Efficacy of Continuous Infusion of Recombinant Factor VIII - Sucrose-formulated (BAY 14 2222) Concentrate in Patients With Hemophilia A Undergoing Major Elective Surgery.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Kogenate (BAY14-2222) | 100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients. |
Timeline
- Start date
- 2004-07-01
- Completion
- 2005-05-01
- First posted
- 2008-02-01
- Last updated
- 2010-04-13
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00606060. Inclusion in this directory is not an endorsement.