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NCT02287558 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide in Hereditary Hemorrhagic Telangiectasia and Transfusion-Dependent Vascular Ectasia: a Phase I Study
A Phase 1 study of Hereditary Hemorrhagic Telangiectasia and Idiopathic Vascular Ectasia, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT02287558: Completed Phase 1 study of Hereditary Hemorrhagic Telangiectasia and Idiopathic Vascular Ectasia, sponsored by The Cleveland Clinic.
NCT02287558 is a Phase 1 study of Hereditary Hemorrhagic Telangiectasia and Idiopathic Vascular Ectasia that has completed, run by The Cleveland Clinic. The registered enrollment target is 9 participants, below the 1,789-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287558, a Phase 1 study of Hereditary Hemorrhagic Telangiectasia and Idiopathic Vascular Ectasia, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate patients \> 18 years of age with transfusion-dependent gastrointestinal bleeding due to documented gastrointestinal vascular ectasia with or without concurrent hereditary hemorrhagic telangiectasia (HHT). This study will focus on documented bleeding sites in the small bowel, including the duodenum, jejunum and ileum. Eligible patients will have endoscopically-documented sites of vascular ectasia and will have required at least 4 units of blood transfusion or episodes of intravenous iron administration over the preceding four months.
Primary Outcome
To compare the requirement for transfusion and intravenous iron administration in individual patients in the 4 month period before initiation of pomalidomide with that over a 4 month period following pomalidomide therapy.
Conditions Studied
Interventions
- DRUG Pomalidomide
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-01-27 |
| Est. Completion | 2019-06-01 |
| Phase | Phase 1 |
What the finished NCT02287558 record still lists
NCT02287558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,789-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Hereditary Hemorrhagic Telangiectasia appearing as the primary indexed condition, and to 1 intervention - of which Pomalidomide is the first listed.
NCT02287558 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02287558 about?
NCT02287558 is a clinical study titled "Pomalidomide in Hereditary Hemorrhagic Telangiectasia and Transfusion-Dependent Vascular Ectasia: a Phase I Study". This study will evaluate patients \> 18 years of age with transfusion-dependent gastrointestinal bleeding due to documented gastrointestinal vascular ectasia with or without concurrent hereditary hemorrhagic telangiectasia (HHT). This study will focus on documented bleeding sites in the small bowel,...
What is the current status of trial NCT02287558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2015-01-27. Estimated completion is 2019-06-01.
What conditions does trial NCT02287558 study?
This clinical trial studies the following conditions: Hereditary Hemorrhagic Telangiectasia, Idiopathic Vascular Ectasia.
What interventions are being tested in trial NCT02287558?
The interventions under investigation include: Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT02287558?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287558 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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