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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.
Full description
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.
Enrollment
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Inclusion criteria
Willing and able to provide written informed consent.
Subjects should be able to follow the instructions for the study drug and be able to complete screening, on-treatment, and post treatment assessments.
Male or female, age above 18 years
Body mass index ( BMI ) between 18 and 32 kg/m2 at Screening.
Confirmation of chronic HCV infection, which meets one of the following: (a) positive for anti-HCV antibodies, HCV RNA or HCV genotyping results within ≤ 6 months of screening, or (b) liver biopsy ≤ 12 months of screening.
HCV RNA above 10^4 IU/mL at Screening by the Central Laboratory.
HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at Screening by the Central Laboratory.
Classification as treatment naïve or treatment experienced (approximately 20% of subjects may be treatment experienced):
Cirrhosis Determination (approximately 20% of subjects may have cirrhosis):
Exclusion criteria
Primary purpose
Allocation
Interventional model
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440 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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