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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362814
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
HCV Drug: Ravidasvir Drug: Danoprevir Drug: Ritonavir Drug: Ribavirin 100 MG Drug: Ravidasvir Placebo Drug: Danoprevir Placebo Drug: Ritonavir Placebo Drug: Ribavirin Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Experimental Group
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
Drug: Ravidasvir
Ravidasvir 200mg tablet administered orally once daily
Other Name: ASC16

Drug: Danoprevir
Danoprevir 100mg tablet administered orally twice daily
Other Name: ASC08

Drug: Ritonavir
Ritonavir 100mg tablet administered orally twice daily

Drug: 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)

Placebo Comparator: Placebo Group
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
Drug: Ravidasvir Placebo
Ravidasvir Placebo tablet administered orally once daily

Drug: Danoprevir Placebo
Danoprevir Placebo tablet administered orally twice daily

Drug: Ritonavir Placebo
Ritonavir Placebo tablet administered orally twice daily

Drug: 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)




Primary Outcome Measures :
  1. Percentage of Participants achieving sustained Virologic response 12 weeks after EOT [ Time Frame: Post treatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy

  2. Adverse events leading to permanent discontinuation of study drug [ Time Frame: baseline to week 12 ]

Secondary Outcome Measures :
  1. Percentage of Participants achieving sustained Virologic response 4 weeks after EOT [ Time Frame: Post treatment Week 4 ]
    SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks after cessation of therapy

  2. Percentage of Participants achieving sustained Virologic response 24 weeks after EOT [ Time Frame: Post treatment Week 24 ]
    SVR24 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 24 weeks after cessation of therapy

  3. Quatitation change of HCV RNA compared to baseline after treatment [ Time Frame: Baseline to week 1 ]
  4. Percentage of participants with viral breakthrough [ Time Frame: Baseline to week 12 ]
    Viral breakthrough was defined as HCV RNA ≥LLOQ after having previously had HCV RNA< LLOQ while receiving treatment, confirmed with 2 consecutive values

  5. Percentage of participants with viral relapse [ Time Frame: End of treatment to post-treatment week 24 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362814


Locations
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China, Beijing
Peking University People's hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Yahong Chen, Master Ascletis Pharmaceuticals Co., Ltd.
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03362814    
Other Study ID Numbers: ASC-ASC16-II/III-CTP-1-01
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
HCV
Ravidasvir
SVR12
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ritonavir
Ribavirin
Lactams
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites
Anti-Bacterial Agents