search
Back to results

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.

Primary Purpose

HCV

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ravidasvir
Danoprevir
Ritonavir
Ribavirin 100 MG
Ravidasvir Placebo
Danoprevir Placebo
Ritonavir Placebo
Ribavirin Placebo
Sponsored by
Ascletis Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV focused on measuring HCV, Ravidasvir, SVR12

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University People's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

Ravidasvir + Danoprevir + Ritonavir + Ribavirin

Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo

Outcomes

Primary Outcome Measures

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
Adverse events leading to permanent discontinuation of study drug

Secondary Outcome Measures

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
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
Quatitation change of HCV RNA compared to baseline after treatment
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
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.

Full Information

First Posted
November 28, 2017
Last Updated
July 25, 2020
Sponsor
Ascletis Pharmaceuticals Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03362814
Brief Title
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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV
Keywords
HCV, Ravidasvir, SVR12

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
Intervention Type
Drug
Intervention Name(s)
Ravidasvir
Other Intervention Name(s)
ASC16
Intervention Description
Ravidasvir 200mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Danoprevir
Other Intervention Name(s)
ASC08
Intervention Description
Danoprevir 100mg tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir 100mg tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ribavirin 100 MG
Intervention Description
Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg)
Intervention Type
Drug
Intervention Name(s)
Ravidasvir Placebo
Intervention Description
Ravidasvir Placebo tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Danoprevir Placebo
Intervention Description
Danoprevir Placebo tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ritonavir Placebo
Intervention Description
Ritonavir Placebo tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ribavirin Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy
Time Frame
Post treatment Week 12
Title
Adverse events leading to permanent discontinuation of study drug
Time Frame
baseline to week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants achieving sustained Virologic response 4 weeks after EOT
Description
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy
Time Frame
Post treatment Week 4
Title
Percentage of Participants achieving sustained Virologic response 24 weeks after EOT
Description
SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy
Time Frame
Post treatment Week 24
Title
Quatitation change of HCV RNA compared to baseline after treatment
Time Frame
Baseline to week 1
Title
Percentage of participants with viral breakthrough
Description
Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values
Time Frame
Baseline to week 12
Title
Percentage of participants with viral relapse
Description
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.
Time Frame
End of treatment to post-treatment week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yahong Chen, Master
Organizational Affiliation
Ascletis Pharmaceuticals Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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.

We'll reach out to this number within 24 hrs