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

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: NCT03020082
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Danoprevir Drug: Ritonavir Drug: peginterferon alfa-2a Drug: RBV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centered, Open Label, Phase III Study on Efficacy, Safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1
Study Start Date : June 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arm Intervention/treatment
Experimental: Danoprevir, Ritonavir, Peg-IFN,RBV
Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.
Drug: Danoprevir
Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
Other Name: ASC08

Drug: Ritonavir
Ritonavir administered orally 100mg BID for 12 weeks;

Drug: peginterferon alfa-2a
PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
Other Name: Peg-IFN

Drug: RBV
RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Other Name: Ribasphere®




Primary Outcome Measures :
  1. Proportion of Participants With Sustained Virologic Response 12 weeks after discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    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: Up to 24 weeks ]

Other Outcome Measures:
  1. Proportion of participants with: HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]


Information from the National Library of Medicine

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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:

  • Willing and able to provide written informed consent
  • Chronic HCV infection (≥ 6 months)
  • Serum HCV RNA of ≥ 1 × 104 IU/mL are documented
  • Hepatitis C virus GT1
  • Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
  • Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa during screening period, or liver biopsy determined 1 year before recruiting (Metavir score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis.
  • 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 (e.g. HH, AIH, Wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)
  • History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients before or during screening , or imaging studies found suspicious nodules, or AFP > 50 ng/mL
  • Positive hepatitis A antibody,positive hepatitis B surface antigen,HIV antibody
  • Presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself.
  • Patients with obvious cardiovascular dysfunction
  • Pregnant or nursing female, nor unwilling to take reliable contraception
  • Others as specified in the 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): NCT03020082


Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Huoling Tang, PhD Ascletis Pharmaceuticals Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03020082    
Other Study ID Numbers: ASC08201503
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.:
Danoprevir
non-cirrhotic
Chinese HCV G1
SVR12
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Ritonavir
Peginterferon alfa-2a
Ribavirin
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