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

Status unconfirmed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00069511

Run by

United Therapeutics

People needed

72

Starts

2003-07-01

Expected to finish

2004-12-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Diabetics are excluded.

Where it is running

• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Tulane Univ. Health Sciences Center — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• UNC Hospital — Chapel Hill, North Carolina, United States
• Memphis Gastroenterology Group — Memphis, Tennessee, United States
• VCU/MCV — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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