Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects.

Ascletis

Status and phase: Completed; Phase 3; Phase 2

Conditions: HCV

Treatments: Drug: Ravidasvir Placebo; Drug: Danoprevir; Drug: Ritonavir Placebo; Drug: Ribavirin 100 MG; Drug: Ravidasvir; Drug: Danoprevir Placebo; Drug: Ribavirin Placebo; Drug: Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT03362814

ASC-ASC16-II/III-CTP-1-01

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infection with Chronic hepatitis C genotype 1confirmed at screening;
• Anti-HCV positive；
• HCV RNA ≥1 × 10000IU / mL;
• Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;
• Non-cirrhotic;
• Voluntarily sign informed consent.

Exclusion criteria

• HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;
• Fibroscan detection result > 12.9kPa or Histopathological examination result of patients is with cirrhosis;
• Past or existing evidence of the presence of non-HCV-induced chronic liver disease;
• Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP>100ng/mL;
• Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;
• BMI<18 or≥30 kg/m2;
• ANC<1.5×109/L、PLT<100×109/L、HB<110g/L（female）or<120g/L（male）；INR>1.5；ALT or AST≥5*ULN；TBIL≥2*ULN（DBIL≥ 35%TBIL）；Cr≥1.5*ULN;
• Others as specified in detailed protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

425 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

Ravidasvir + Danoprevir + Ritonavir + Ribavirin

Treatment:

Drug: Ribavirin 100 MG

Drug: Ritonavir

Drug: Ravidasvir

Drug: Danoprevir

Placebo Group

Placebo Comparator group

Description:

Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo

Treatment:

Drug: Ribavirin Placebo

Drug: Ritonavir Placebo

Drug: Ravidasvir Placebo

Drug: Danoprevir Placebo