Trials / Completed
CompletedNCT00157053
Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- 10 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antihemophilic factor, recombinant, manufactured protein-free |
Timeline
- Start date
- 2001-11-22
- Primary completion
- 2004-08-03
- Completion
- 2004-08-03
- First posted
- 2005-09-12
- Last updated
- 2021-08-24
Locations
24 sites across 9 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00157053. Inclusion in this directory is not an endorsement.