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NCT03910244 · ClinicalTrials.gov registry record · Phase 2
Pomalidomide for the Treatment of Bleeding in HHT
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
NCT03910244: Completed Phase 2 study, sponsored by The Cleveland Clinic.
NCT03910244 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 145 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03910244, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
Study Summary
This is a Phase II placebo-controlled double-blind study of pomalidomide in patients with hereditary hemorrhagic telangiectasia (HHT) with moderate to severe epistaxis who have anemia and/or require parenteral iron infusions or blood transfusions. A total of 159 patients will be randomized 2:1 to treatment with oral pomalidomide or matching placebo for 24 weeks. Mean change from baseline to 24 weeks in the Epistaxis Severity Score (ESS) will be compared between treatment groups to determine pomalidomide efficacy.
Primary Outcome
The primary outcome measure is the change from baseline in Epistaxis Severity Score (ESS) after 6 months of treatment administration to compare the outcomes of Pomalidomide versus Placebo. The ESS ranges from 0-10 with higher scores indicating worse condition in the prior 4 weeks. The minimal important difference is 0.71
Interventions
- DRUG Placebo oral capsule
- DRUG Pomalidomide Oral Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 2 |
What the finished NCT03910244 record still lists
NCT03910244 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03910244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03910244 about?
NCT03910244 is a clinical study titled "Pomalidomide for the Treatment of Bleeding in HHT". This is a Phase II placebo-controlled double-blind study of pomalidomide in patients with hereditary hemorrhagic telangiectasia (HHT) with moderate to severe epistaxis who have anemia and/or require parenteral iron infusions or blood transfusions. A total of 159 patients will be randomized 2:1 to tr...
What is the current status of trial NCT03910244?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2019-10-17. Estimated completion is 2023-09-08.
What interventions are being tested in trial NCT03910244?
The interventions under investigation include: Placebo oral capsule (DRUG), Pomalidomide Oral Product (DRUG).
Who is sponsoring clinical trial NCT03910244?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03910244's enrollment target sits among peer trials
145 498th of 2000 higher than 1,501 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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