Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
Summary
This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of
two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily
for 48 weeks and no treatment in patients chronically infected with hepatitis C who are
nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated
during at least 24 weeks of no treatment in IRHC-001.
At the time of randomization into IRHC-001, the no treatment arm patients will be
concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) +
Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be
eligible for consideration to receive treatment in IRHC-002 until they have completed a
minimum of 24 weeks of participation in IRHC-001.
The protocol and informed consent form that will be used must be approved by the
Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the
study is initiated.
Phase:
Phase 3
Details
Lead Sponsor:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.