NCT00588146

Phase 2 Study of PEG-Intron in Hereditary Hemorrhagic Telangiectasia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Anemia
• Liver Disease
• Hypoxemia

Interventions

Type	Name	Description
DRUG	Pegylated Interferon Alpha2b	Weekly subcutaneous injection of 1 microgram/kg/week
OTHER	Standard care	Standard care

Timeline

• Start date: 2007-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-01-08
• Last updated: 2013-02-22
• Results posted: 2013-01-28

Locations

1 site across 1 country: United States