12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.
- Conditions
- Hepatitis C
- Registration Number
- NCT00069511
- Lead Sponsor
- United Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- 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.
- Diabetics are excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
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
Shands Hospital at the University of Florida🇺🇸Gainesville, Florida, United States