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.

NCT03362814 | Completed Phase 2

• 1 other identifier: ASC-ASC16-II/III-CTP-1-01
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HCV

Keywords

HCV; Ravidasvir; SVR12

Outcome Measures

Primary Outcomes (2)

• 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

• Adverse events leading to permanent discontinuation of study drug

  baseline to week 12

Secondary Outcomes (5)

• Percentage of Participants achieving sustained Virologic response 4 weeks after EOT

  Post treatment Week 4

• Percentage of Participants achieving sustained Virologic response 24 weeks after EOT

  Post treatment Week 24

• Quatitation change of HCV RNA compared to baseline after treatment

  Baseline to week 1

• Percentage of participants with viral breakthrough

  Baseline to week 12

• Percentage of participants with viral relapse

  End of treatment to post-treatment week 24

Study Arms (2)

Experimental Group

EXPERIMENTAL

Ravidasvir + Danoprevir + Ritonavir + Ribavirin

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

Placebo Group

PLACEBO COMPARATOR

Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo

Drug: Ravidasvir Placebo; Drug: Danoprevir Placebo; Drug: Ritonavir Placebo; Drug: Ribavirin Placebo

Interventions

Ravidasvir DRUG

Ravidasvir 200mg tablet administered orally once daily

Also known as: ASC16

Experimental Group

Danoprevir DRUG

Danoprevir 100mg tablet administered orally twice daily

Also known as: ASC08

Experimental Group

Ritonavir DRUG

Ritonavir 100mg tablet administered orally twice daily

Experimental Group

Ribavirin 100 MG DRUG

Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(\<75kg = 1000mg and ≥75kg = 1200mg)

Experimental Group

Ravidasvir Placebo DRUG

Ravidasvir Placebo tablet administered orally once daily

Placebo Group

Danoprevir Placebo DRUG

Danoprevir Placebo tablet administered orally twice daily

Placebo Group

Ritonavir Placebo DRUG

Ritonavir Placebo tablet administered orally twice daily

Placebo Group

Ribavirin Placebo DRUG

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)

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Peking University People's hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

ravidasvir; danoprevir; Ritonavir; Ribavirin

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yahong Chen, Master

  Ascletis Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 5, 2017
• Study Start: July 1, 2017
• Primary Completion: December 12, 2018
• Study Completion: April 24, 2019
• Last Updated: July 28, 2020

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)