Hepatitis C Clinical Trial
Official title:
A Phase 2b Study of Merimepodib in Combination With Pegylated Interferon Alfa-2a (Pegasys®) and Ribavirin in Subjects With Chronic Hepatitis C Non-Responsive to Prior Therapy With Pegylated Interferon Alfa and Ribavirin
This trial is designed to test whether or not the addition of merimepodib (MMPD) to the
standard therapy of pegylated interferon and ribavirin will result in a positive treatment
response for people who have not previously responded to this therapy. Approximately 315
subjects will be enrolled in this research study at approximately 55 clinical sites in the
United States. There will be three study groups. Everyone in the study will receive Pegasys®
(pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the
groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each
dose level being tested. The third group will take a placebo instead of MMPD, with the
Pegasys® and Copegus®.
After the first 24 weeks of treatment, blood tests will be done to see if subjects are
responding to treatment. If they are responding, they will continue receiving study
treatment in the study for another 24 weeks. If they are not responding, they will stop
study treatment. Everyone who is responding will be monitored for 24 weeks after the last
dose of medication, to see how long the response lasts.
Evaluations will be performed during the study to look at the safety of the
Pegasys®/Copegus® and MMPD or placebo combination, and to see how the combination is working
by measuring Hepatitis C Virus in the blood.
At some of the clinical sites performing the study, some subjects may also participate in
additional testing to look at the metabolism of the drugs, or to look at the immune response
to Hepatitis C virus infection and treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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