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

Ascletis

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Ritonavir; Drug: Danoprevir; Drug: peginterferon alfa-2a; Drug: Ribavirin (RBV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03020004

ASC08201502

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Danoprevir,Ritonavir, Peg-IFN,RBV

Experimental group

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.

Treatment:

Drug: peginterferon alfa-2a

Drug: Ribavirin (RBV)

Drug: Ritonavir

Drug: Danoprevir