Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
This is an adaptive Phase I study to evaluate RO5024048 in the following groups:
- Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed
- Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy
(Part 2- Multiple Ascending Dose Study)-Enrollment Completed
- HCV genotype 1-infected patients who are treatment naive, to be dosed in combination
with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling
- HCV genotype 2-3 infected patients who have previously been treated with interferon but
who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 -
Combination Dose Study)- Currently enrolling
The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in
people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured
during the study and the amount of hepatitis C virus in the blood after each dose will also
be measured.
During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently
used and approved for the treatment of HCV.