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.

HCV Clinical Trial

Official title:

A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362814
• Other study ID #: ASC-ASC16-II/III-CTP-1-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: November 2017
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: April 24, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HCV
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Ravidasvir
Ravidasvir 200mg tablet administered orally once daily
• Danoprevir
Danoprevir 100mg tablet administered orally twice daily
• Ritonavir
Ritonavir 100mg tablet administered orally twice daily
• Ribavirin 100 MG
Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and =75kg = 1200mg)
• Ravidasvir Placebo
Ravidasvir Placebo tablet administered orally once daily
• Danoprevir Placebo
Danoprevir Placebo tablet administered orally twice daily
• Ritonavir Placebo
Ritonavir Placebo tablet administered orally twice daily
• Ribavirin Placebo
Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and =75kg = 6 tablets)

Locations

Country	Name	City	State
China	Peking University People's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants achieving sustained Virologic response 12 weeks after EOT	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy	Post treatment Week 12
Primary	Adverse events leading to permanent discontinuation of study drug		baseline to week 12
Secondary	Percentage of Participants achieving sustained Virologic response 4 weeks after EOT	SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy	Post treatment Week 4
Secondary	Percentage of Participants achieving sustained Virologic response 24 weeks after EOT	SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy	Post treatment Week 24
Secondary	Quatitation change of HCV RNA compared to baseline after treatment		Baseline to week 1
Secondary	Percentage of participants with viral breakthrough	Viral breakthrough was defined as HCV RNA =LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values	Baseline to week 12
Secondary	Percentage of participants with viral relapse	Viral relapse was defined as HCV RNA =LLOQ during the post treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values.	End of treatment to post-treatment week 24