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

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: NCT03020004
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : February 7, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Danoprevir,Ritonavir, Peg-IFN,RBV
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.
Drug: Danoprevir
Danoprevir (DNV) 100mg tablet administered orally twice daily
Other Name: ASC08

Drug: Ritonavir
Ritonavir 100mg tablet administered orally twice daily

Drug: peginterferon alfa-2a
PegIFN subcutaneous injection at 180 mcg weekly
Other Name: PegIFN

Drug: Ribavirin (RBV)
Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)
Other Name: Ribasphere®




Primary Outcome Measures :
  1. Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment [ Time Frame: 24 weeks ]
    SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration



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) ;
  • 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

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): NCT03020004


Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Huoling Tang, PhD Ascletis Pharmaceuticals Co., Ltd.
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03020004    
Other Study ID Numbers: ASC08201502
First Posted: January 13, 2017    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: July 26, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
Danoprevir
SVR12
Chinese HCV G1
non-cirrhotic
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
Ribavirin
Peginterferon alfa-2a
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