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NCT00157040 · ClinicalTrials.gov registry record · Phase 2
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00157040: Completed Phase 2 study, sponsored by Baxalta now part of Shire.
NCT00157040 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00157040, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Terminal phase half-life of rAHF-PFM was to be determined using the biphasic linear regression model.
Interventions
- DRUG Antihemophilic factor, recombinant, manufactured protein-free
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2002-06-07 |
| Est. Completion | 2005-01-04 |
| Phase | Phase 2 |
What the finished NCT00157040 record still lists
NCT00157040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Antihemophilic factor, recombinant, manufactured protein-free is the first listed.
NCT00157040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00157040 about?
NCT00157040 is a clinical study titled "Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A". 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.
What is the current status of trial NCT00157040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2002-06-07. Estimated completion is 2005-01-04.
What interventions are being tested in trial NCT00157040?
The interventions under investigation include: Antihemophilic factor, recombinant, manufactured protein-free (DRUG).
Who is sponsoring clinical trial NCT00157040?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00157040's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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