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NCT00243386 · ClinicalTrials.gov registry record · Phase 4
Prophylaxis 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
- 82
- Enrollment target
NCT00243386 is a Phase 4 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 82 participants.
The verdict
NCT00243386, a Phase 4 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.
Interventions
- DRUG Antihemophilic factor, recombinant, manufactured protein-free
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2006-01-04 |
| Est. Completion | 2010-06-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00243386
The ClinicalTrials.gov registry entry for NCT00243386 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Antihemophilic factor, recombinant, manufactured protein-free is the first listed.
NCT00243386 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00243386 about?
NCT00243386 is a clinical study titled "Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A". The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) wi...
What is the current status of trial NCT00243386?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2006-01-04. Estimated completion is 2010-06-16.
What interventions are being tested in trial NCT00243386?
The interventions under investigation include: Antihemophilic factor, recombinant, manufactured protein-free (DRUG).
Who is sponsoring clinical trial NCT00243386?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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