At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia
In Brief
A Phase 2 clinical trial evaluating Pomalidomide Oral Product and Placebo oral capsule for Telangiectasia, Hereditary Hemorrhagic. Completed, enrolled 145 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
Pomalidomide, a third generation derivative of thalidomide, given orally at a starting dose of 4 mg/day for days 1-28 of six 28-day cycles. The dose may be reduced to 3 or 2 mg/day based on specific adverse event (AE) criteria.
Matching placebo will be given.