drugset / Trial / NCT00433069

Retreatment of Chronic Hepatitis C Non-responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone

NCT00433069

Phase 2 Completed 5 enrolled University Hospital, Geneva
NaSingle-groupOpen-labelTreatment

Summary

The aim of this study is to investigate the efficacy and safety of an insulin-sensitizer (Actos) added to a standard Pegasys/Copegus combination therapy of chronic hepatitis C in patients who have previously failed a pegylated-interferon-alpha / ribavirin combination without the insulin sensitizer. The primary endpoint is the initial virological response (level of HCV RNA in serum) as evaluated after 12 weeks of triple therapy.

Timeline

Start
2007-01
Primary completion
2007-12
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule 15 mg
Background Ribavirin Small molecule 1000 mg
Background Ribavirin Small molecule 1200 mg
Background interferon alfa Protein / enzyme biologic 180 ug