12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.

• Status: Unknown status
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center study. Neither the study subjects nor the physicians will know what treatment an individual subject is receiving. Subjects will be randomly assigned (like flipping a coin) to one of five treatment groups. The treatment groups include four different dosing groups of active study drug and one group of subjects who will receive placebo. A 12 week follow up period occurs after the 12 weeks of dosing. The study endpoint is a reduction in Hepatitis C viral load.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics

Criteria

Inclusion Criteria:

• Patients must be adults,

• have a positive Hepatitis C antibody test,

• and be genotype 1, with a minimum of 100,000 IU of Hepatitis C virus by nucleic acid testing, be non-cirrhotic with a Metavir score of F0-3 (or equivalent) on liver biopsy, and have failed previous therapy with Interferon or Peg Interferon monotherapy, Interferon plus ribavirin, or Peg Interferon and ribavirin.

Exclusion Criteria:

• Diabetics are excluded.