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Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan

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. Identifier: NCT03020095
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Ravidasvir Drug: Danoprevir Drug: Ritonavir Drug: Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study To Investigate the Efficacy, Safety And Pharmacokinetics Of Ravidasvir In Combination With Ritonavir-boosted Danoprevir And Ribavirin In Treatment-naive Non-cirrhotic Taiwanese Patients Who Have Chronic Hepatitis C Genotype 1
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ravidasvir,Danoprevir/r,RBV
Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
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
Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally
Other Name: Ribasphere®

Primary Outcome Measures :
  1. Proportion of participants with Sustained Virologic Response 12 weeks after end of treatment (SVR12) [ Time Frame: 12 weeks ]
    SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration

Secondary Outcome Measures :
  1. Proportion of participants permanently discontinuing study drug(s) due to an adverse event (AE) [ Time Frame: 24 weeks ]
  2. Proportion of participants with Sustained virologic response 24 weeks after end of treatment [ Time Frame: 24 weeks ]
    SVR24, defined as undetectable HCV RNA 24 weeks after the last day of study drug administration

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥6 months) , HCV RNA ≥ 1 × 104 IU/mL
  • Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
  • Chronic liver disease consistent with CHC infection without cirrhosis as determined by biopsy obtained within the past calendar 36 months using one of the liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 3 years will have a study related Fibroscan performed in order to confirm the diagnosis. Liver biopsy will be performed by investigator's judgement
  • All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
  • Others as specified in detailed protocol.

Exclusion Criteria:

  • Pregnant or lactating women.
  • History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, HCC, or bleeding esophageal varices)
  • Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
  • Positive hepatitis B surface antigen or HIV antibody at screening
  • History or presence of liver cirrhosis
  • History of severe psychiatric disease, including psychosis and/or depression, who is not able to participate or able to give written informed consent and to comply with the study restrictions
  • History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)
  • History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months). Patients with stable coronary artery disease (e.g., 6 months after by-pass surgery, angioplasty with or without stent placement, etc.) as confirmed by a cardiologist will be permitted. In addition, patients with documented or presumed unstable coronary artery disease, cardiovascular disease, or cerebrovascular disease should not be enrolled.
  • Any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, or spherocytosis) or for whom anemia would be medically problematic
  • History of pre-existing renal disease, patients with a history of nephrolithiasis will be allowed
  • 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 identifier (NCT number): NCT03020095

Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
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Study Director: Huoling Tang, PhD Ascletis Pharmaceuticals Co., Ltd.
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd. Identifier: NCT03020095    
Other Study ID Numbers: ASC162001
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
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