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NCT03272568 · ClinicalTrials.gov registry record · Early Phase 1
Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers
A Early Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT03272568 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 3 participants.
The verdict
NCT03272568, a Early Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this feasibility study is to find out if two clotting factor products, Eloctate \[hemophilia A\] and Alprolix \[hemophilia B\], can reduce the amount of menstrual bleeding in female hemophilia A and B carriers (14 years of age or older) who have severe or heavy bleeding. These products are FDA-approved for use in males with hemophilia A and B to prevent and treat bleeding. They are not approved specifically to reduce menstrual bleeding, but may be useful for this purpose. Both products have an "extended half life" which means they circulate in the body longer than other FVIII or FIX products. The study team will gather additional information about the safety of these drugs and how well they work. The results of this feasibility study will provide information for an upcoming larger study.
Interventions
- DRUG Recombinant FVIII Fc fusion product Eloctate
- DRUG Recombinant FIX Fc fusion product Alprolix
- DEVICE Patient-operated diagnostic device for anemia AnemoCheck.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2019-12-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03272568
The ClinicalTrials.gov registry entry for NCT03272568 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Recombinant FVIII Fc fusion product Eloctate is the first listed.
NCT03272568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03272568 about?
NCT03272568 is a clinical study titled "Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers". The purpose of this feasibility study is to find out if two clotting factor products, Eloctate \[hemophilia A\] and Alprolix \[hemophilia B\], can reduce the amount of menstrual bleeding in female hemophilia A and B carriers (14 years of age or older) who have severe or heavy bleeding. These product...
What is the current status of trial NCT03272568?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2018-02-14. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03272568?
The interventions under investigation include: Recombinant FVIII Fc fusion product Eloctate (DRUG), Recombinant FIX Fc fusion product Alprolix (DRUG), Patient-operated diagnostic device for anemia AnemoCheck. (DEVICE).
Who is sponsoring clinical trial NCT03272568?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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