Chronic Hepatitis C Clinical Trial
Official title:
A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy and During at Least 24 Weeks of No Treatment in IRHC-001
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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