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OpenTrials
Completed

NCT Number: NCT03020082

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

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.

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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)
  • 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

Treatment and study plan

Danoprevir

Drug

Danoprevir (DNV)administered orally 100mg BID for 12 weeks;

Other names: ASC08

Ritonavir

Drug

Ritonavir administered orally 100mg BID for 12 weeks;

Peginterferon alfa-2a

Drug

PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;

Other names: Peg-IFN

RBV

Drug

RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.

Other names: Ribasphere®

Primary outcomes

  1. Proportion of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Mar 23, 2021

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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