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NCT00289536 · ClinicalTrials.gov registry record · Phase 4
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
A Phase 4 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT00289536: Completed Phase 4 study, sponsored by Baxalta now part of Shire.
NCT00289536 is a Phase 4 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00289536, a Phase 4 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate. A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.
Primary Outcome
Percent increase in factor VIII concentration per dose from pre- to post-infusion
Interventions
- BIOLOGICAL Antihemophilic factor, recombinant, manufactured protein-free
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2006-02-02 |
| Est. Completion | 2007-04-01 |
| Phase | Phase 4 |
What the finished NCT00289536 record still lists
NCT00289536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Antihemophilic factor, recombinant, manufactured protein-free is the first listed.
NCT00289536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00289536 about?
NCT00289536 is a clinical study titled "Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A". The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatmen...
What is the current status of trial NCT00289536?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2006-02-02. Estimated completion is 2007-04-01.
What interventions are being tested in trial NCT00289536?
The interventions under investigation include: Antihemophilic factor, recombinant, manufactured protein-free (BIOLOGICAL).
Who is sponsoring clinical trial NCT00289536?
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 NCT00289536's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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