A Multi-Centered, Prospective, Randomized, Placebo-Controlled Clinical Trial for the Treatment of Significant Steatosis or NASH With Xenical Followed by Treatment of Hepatitis C (HCV) With PEG-Interferon Alpha-2a/Copegus (HCVNASH)

NCT00207311 Phase 4 COMPLETED

This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of \> 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.

Details

Lead sponsor	Brooke Army Medical Center
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2005-08
Completion	2009-05

Conditions

• Fatty Liver
• Hepatitis C

Interventions

• Xenical, Pegasys, Copegus
• Xenicare Program

Primary outcomes

• Sustained virological response (SVR) defined as the percentage of participants with undetectable HCV-RNA as measured by the Roche AMPLICORTM HCV Test, v 2.0 (detection limit 50 IU/mL) at 24 weeks post completion of the treatment period — 110 weeks

Countries

United States