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NCT00141843 · ClinicalTrials.gov registry record · Phase 3
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT00141843 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 100 participants.
The verdict
NCT00141843, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
Interventions
- GENETIC ReFacto AF
- GENETIC B-Domain deleted Recombinant Factor VIII
- GENETIC BDDrFVIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2005-07 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00141843
The ClinicalTrials.gov registry entry for NCT00141843 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ReFacto AF is the first listed.
NCT00141843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00141843 about?
NCT00141843 is a clinical study titled "Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A". The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemoph...
What is the current status of trial NCT00141843?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2005-07. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00141843?
The interventions under investigation include: ReFacto AF (GENETIC), B-Domain deleted Recombinant Factor VIII (GENETIC), BDDrFVIII (GENETIC).
Who is sponsoring clinical trial NCT00141843?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
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