Trials / Completed
CompletedNCT00666406
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A: a Phase IV, Prospective, Randomized, Controlled, Cross-over, Single Center Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 15 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) | Infusion of 50 +/- 5 IU/kg bodyweight |
| DRUG | Recombinant Factor VIII (rAHF) | Infusion of 50 +/- 5 IU/kg bodyweight |
Timeline
- Start date
- 2008-03-31
- Primary completion
- 2009-02-18
- Completion
- 2009-02-18
- First posted
- 2008-04-24
- Last updated
- 2021-05-19
- Results posted
- 2013-03-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00666406. Inclusion in this directory is not an endorsement.