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NCT00037557 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating rFIX; BeneFIX in Severe Hemophilia B
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00037557 is a Phase 3 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 20 participants.
The verdict
NCT00037557, a Phase 3 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit a different pharmacokinetic profile and therefore may respond differently to rFIX infusions when compared with older children and adults. This evaluation will provide data from which recommendations can be made regarding rFIX dosing and treatment of these patients. Surveillance for certain observations that have been made in patients treated with rFIX in the clinical and postmarketing setting will be performed, including inhibitor development, thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC agglutination. Comparisons will be derived from published reports and communications describing experience with other FIX products and protein therapeutics in general.
Interventions
- DRUG BeneFIX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2002-09 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00037557
The ClinicalTrials.gov registry entry for NCT00037557 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 20 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 1 intervention - of which BeneFIX is the first listed.
NCT00037557 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00037557 about?
NCT00037557 is a clinical study titled "Study Evaluating rFIX; BeneFIX in Severe Hemophilia B". To characterize the safety and efficacy of rFIX in children less than 6 years of age with severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery. This study will provide an opportunity for systematic observation of treatment with rFIX in children less than 6 year...
What is the current status of trial NCT00037557?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2002-09. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00037557?
The interventions under investigation include: BeneFIX (DRUG).
Who is sponsoring clinical trial NCT00037557?
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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