Anemia Clinical Trial
Official title:
Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia
The purpose of the study is to evaluate the safety and tolerability of pegylated interferon
alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary
hemorrhagic telangiectasia (HHT).
Funding Source - FDA Office of Orphan Products Development (OOPD)
The objective of this study is to evaluate the safety and tolerability of pegylated interferon alpha-2b (PEG-Intron) in patients with severe complications related to Hereditary Hemorrhagic Telangiectasia (HHT). Participants will be randomized to the treatment arm or control arm and then crossed over to the alternate arm at 6 months for the remainder of the 12-month study. Study treatment will consist of weekly subcutaneous injections of pegylated interferon alpha-2b (PEG-Intron), 1 microgram/kilogram/week. Adverse events as well as monitoring and treatment of toxicities will be followed as stated in the protocol. Adverse events will be graded according to the Modified NCI Common Toxicity Criteria. After every five participants have completed one month of treatment, an independent data safety monitoring board will review any adverse events. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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