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OpenTrials
Completed

NCT Number: NCT03020004

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danoprevir

Drug

Danoprevir (DNV) 100mg tablet administered orally twice daily

Other names: ASC08

Ritonavir

Drug

Ritonavir 100mg tablet administered orally twice daily

Peginterferon alfa-2a

Drug

PegIFN subcutaneous injection at 180 mcg weekly

Other names: PegIFN

ribavirin (RBV)

Drug

Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)

Other names: Ribasphere®

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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