Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.
It is estimated that China has a population of over 10 million infected with HCV and also a highly variable HCV genotype geographic distribution. A simple, universal, non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical practice and public health. The combination regimen of SH229 and DCV is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
SH229 400 mg was provided in 4 tablets, 100mg each;SH229 600 mg was provided in 6 tablets , 100mg each;SH229 800 mg in was provided in 8tablets , 100mg each。
Daclatasvir dihydrochloride was provided in a single tablet of 60 mg.
The First Hospital of Jilin University
Jilin, Jiangsu, China
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 12 weeks after end of treatment
Rapid virologic response at 4 week after initiation of treatment (RVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 4 week after initiation of treatment
Rapid virologic response at 12 weeks after initiation of treatment (RVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 12 weeks after initiation of treatment
Sustained virologic response at 4 weeks after end of treatment (SVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 4 weeks after end of treatment
Sustained virologic response at 24 weeks after end of treatment (SVR24)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 24 weeks after end of treatment
Virologic breakthrough
Percentage of subjects with on-treatment re-detected plasma HCV RNA after HCV RNA below the lower limit of quantitation
Time frame: 2, 4, 8 and 12 weeks after initiation of treatment
Virologic relapse
Percentage of subjects with off-treatment re-detected plasma HCV RNA after end-of-treatment HCV RNA below the lower limit of quantitation
Time frame: 4 and 12 weeks after end of treatment
Antiviral effects of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets , as measured by HCV RNA levels
To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment
Time frame: Up to 36 weeks
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