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TMC435HPC2002 - Phase II Trial of TMC435 in Combination With PSI-7977 in Prior G1 Null Responders to Peg-IFN/RBV, Hepatitis C-Infected Patients
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This study is currently recruiting participants.
Verified February 2012 by Tibotec Pharmaceuticals, Ireland
http://clinicaltrials.gov/ct2/show/NCT01466790?term=hepatitis+C+AND+TMC+435&rank=1
TMC435+PSI-7977 with & without ribavirin for either 12 or 24 weeks total duration of therapy
This is a randomized (study drug assigned by chance), open-label ( patients and physicians know the names of the drugs they are taking), Phase IIa trial with TMC435 and PSI-7977 with or without ribavirin (RBV) in patients who are infected with chronic genotype 1 hepatitis C and who have failed standard treatment with pegylated interferon (PegIFN) and ribavirin (RBV).
The study will investigate the efficacy and safety of four different regimens: two arms will receive 12 weeks of treatment and two arms will receive 24 weeks of treatment. A target of 90 subjects will be randomly assigned to 4 treatment arms in the first study cohort (Cohort 1), which includes patients with lower stages of liver fibrosis (Metavir F0, F1, and F2). The trial will consist of a screening period of maximum 6 weeks, a 12-week or 24-week treatment period and a follow-up period.
Once treatment results are available on all patients in Cohort 1, the second cohort (Cohort 2) will begin enrollment in the study. A target of 90 patients will be enrolled in Cohort 2. Enrollment criteria will be the same as for Cohort 1, except that only patients with more advanced liver fibrosis (Metavir stage F3 or F4), will be enrolled. The treatment arms to be included in Cohort 2 will be determined by the results from the data analysis in Cohort 1.
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