This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin(RBV) in the treatment of Chronic hepatitis C who have not been previously treated with Interferon(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.
Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be 24 or 48 weeks corresponding to different HCV genotype, genotype 2,3 and non-genotype2,3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical Unbiversity
Guangzhou, Guangdong, China
cEVR (complete early virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12
Time frame: weeks 12 of study therapy
Proportion of patients who had undetectable plasma HCV RNA
Time frame: weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment
HCV RNA load reduction
Time frame: weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment
eRVR ( extended rapid virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 4 and 12
Time frame: weeks 4 and 12 of study therapy
Breakthrough
defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)
Time frame: weeks 24, 48 of study therapy
Relapse
defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after then
Time frame: 12 and 24 weeks after the end of treatment
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The third people's hospital of Shenzhen
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
...and 42 more locations