Clinical Trial: Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia

Brief Summary:

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)


Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: Change in Hemoglobin [ Time Frame: baseline, one year ]

The hemoglobin level is expressed as the amount of hemoglobin in grams (gm) per deciliter (dL) of whole blood.


Original Primary Outcome: Improvement of hemoglobin, liver disease, or hypoxemia [ Time Frame: 1 year ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: December 26, 2007
Date Started: January 2007
Date Completion:
Last Updated: February 19, 2013
Last Verified: February 2013