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Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Danoprevir
Ritonavir
peginterferon alfa-2a
Ribavirin (RBV)
Sponsored by
Ascletis Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Danoprevir, SVR12, Chinese HCV G1, non-cirrhotic

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥ 6 months) ;
  • Positive HCV antibody
  • Serum HCV RNA of ≥ 1 × 104 IU/mL
  • Hepatitis C virus GT1
  • Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
  • 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 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
  • Others as specified in the detailed protocol

Exclusion Criteria:

  • Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients
  • 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
  • Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL
  • Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
  • Others as specified in the detailed protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Danoprevir,Ritonavir, Peg-IFN,RBV

    Arm Description

    Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
    SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    June 27, 2018
    Sponsor
    Ascletis Pharmaceuticals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03020004
    Brief Title
    Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
    Official Title
    A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C
    Keywords
    Danoprevir, SVR12, Chinese HCV G1, non-cirrhotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Danoprevir,Ritonavir, Peg-IFN,RBV
    Arm Type
    Experimental
    Arm Description
    Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Danoprevir
    Other Intervention Name(s)
    ASC08
    Intervention Description
    Danoprevir (DNV) 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)
    peginterferon alfa-2a
    Other Intervention Name(s)
    PegIFN
    Intervention Description
    PegIFN subcutaneous injection at 180 mcg weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin (RBV)
    Other Intervention Name(s)
    Ribasphere®
    Intervention Description
    Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)
    Primary Outcome Measure Information:
    Title
    Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
    Description
    SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing and able to provide written informed consent Chronic HCV infection (≥ 6 months) ; Positive HCV antibody Serum HCV RNA of ≥ 1 × 104 IU/mL Hepatitis C virus GT1 Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV 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 1 years will have a study related Fibroscan performed in order to confirm the diagnosis Others as specified in the detailed protocol Exclusion Criteria: Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for liver cirrhosis patients 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 Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP > 50 ng/mL Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening Others as specified in the detailed protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huoling Tang, PhD
    Organizational Affiliation
    Ascletis Pharmaceuticals Co., Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

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