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NCT03587116 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 212
- Enrollment target
NCT03587116 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 212 participants.
The verdict
NCT03587116, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 212 participants
- Enrollment target
Study Summary
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study. The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.
Interventions
- DRUG Standard of Care FVIII Replacement therapy
- DRUG Standard of Care FIX Replacement therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2024-12-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03587116
The ClinicalTrials.gov registry entry for NCT03587116 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard of Care FVIII Replacement therapy is the first listed.
NCT03587116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03587116 about?
NCT03587116 is a clinical study titled "A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)". To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prop...
What is the current status of trial NCT03587116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 212 participants. The study started on 2018-07-26. Estimated completion is 2024-12-13.
What interventions are being tested in trial NCT03587116?
The interventions under investigation include: Standard of Care FVIII Replacement therapy (DRUG), Standard of Care FIX Replacement therapy (DRUG).
Who is sponsoring clinical trial NCT03587116?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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