12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
This trial is active, not recruiting.
|Start date||July 2003|
|End date||December 2004|
|Trial size||72 participants|
|Trial identifier||NCT00069511, UT-231B-02:01|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Gainesville, FL||Shands Hospital at the University of Florida||no longer recruiting|
|New Orleans, LA||Tulane Univ. Health Sciences Center||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Chapel Hill, NC||UNC Hospital||no longer recruiting|
|Memphis, TN||Memphis Gastroenterology Group||no longer recruiting|
|Richmond, VA||VCU/MCV||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 18 years up to 65 years old.
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.
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