Trials / Completed
CompletedNCT00157040
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
Recombinant Antihemophilic Factor (rAHF-PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Pharmacokinetics, Immunogenicity, Efficacy and Safety in Previously Treated Pediatric Patients With Hemophilia A
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 50 (planned)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antihemophilic factor, recombinant, manufactured protein-free |
Timeline
- Start date
- 2002-06-07
- Primary completion
- 2005-01-04
- Completion
- 2005-01-04
- First posted
- 2005-09-12
- Last updated
- 2021-04-27
Locations
12 sites across 3 countries: United States, Canada, Puerto Rico
Source: ClinicalTrials.gov record NCT00157040. Inclusion in this directory is not an endorsement.