This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combination treatment, compared with the placebo add-on.
Eligible subjects with written informed consent will be stratified according to their baseline HCV RNA (≤800,000 IU/mL versus\>800,000 IU/mL), stage of liver fibrosis (METAVIR system fibrosis score of 0 1 versus 2 3). During the 48 week Treatment Period and 24 week Follow up Period, subjects will be assessed at regular intervals for efficacy and safety at Weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. If possible, subjects who prematurely discontinue the study during the Treatment Period will have samples taken for hematology, biochemistry and urinalysis in the same week of discontinuation as well as 24 weeks after discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Peking University People's Hospit
Beijing, Beijing Municipality, China
Chang Gung Memorial Hospital
Taoyuan, Taiwan
sustained virologic response (SVR) rate
undetectable HCV RNA 24 weeks after the EOT.
Time frame: 24 weeks after the end of treatment (EOT, 48 weeks)
Virologic response (VR)
undetectable HCV RNA at the EOT.
Time frame: at the EOT (48 weeks)
relapse rate
undetectable HCV RNA at the EOT followed by a positive HCV RNA level within 24 weeks after the EOT
Time frame: 24 weeks after the EOT
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Placebo, without acting ingredient.