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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: Completed Early Phase 1 study, sponsored by Emory University.
NCT03272568 is a Early Phase 1 study that has completed, run by Emory University. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Menstrual loss is tracked via paper and electronic PBAC, calculated via visual interpretation centrally and correlated to the ability of a participant to correctly assign pad or tampon saturation. The PBAC will be estimated (mean) over the three-month intervention period to assess if 30% reduction in menstrual bleeding was achieved. PBAC is a semi-quantitative, self-administered pictorial tool. The total score is calculated by adding up the sum of all scores for the tampons or pads used, with a
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 |
What the finished NCT03272568 record still lists
NCT03272568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Recombinant FVIII Fc fusion product Eloctate is the first listed.
NCT03272568 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03272568's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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