This study is to confirm the potential effects and assess the safety 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.
Total 720 subjects are divided into two groups and treated separately according to the HCV genotype(genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
719
SVR (sustained virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at 24 weeks after the end of treatment
Time frame: 24 weeks after 24 or 48 weeks of study therapy
RVR(rapid virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 4
Time frame: weeks 4 of study therapy
cEVR (complete early virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 12
Time frame: weeks 12 of study therapy
ETVR( end of treatment virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at the end of treatment
Time frame: weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
eRVR ( extended rapid virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 4 and 12
Time frame: weeks 4 and 12 of study therapy
No-responses
defined as the proportion of patients who had less than a \<2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24
Time frame: weeks 12 or weeks 24 of study therapy
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First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical Unbiversity
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Union hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
...and 31 more locations
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 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
Relapse
defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then
Time frame: 12 and 24 weeks after 24 or 48 weeks of study therapy