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

NCT ID: NCT03020004

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-02-28

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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Danoprevir

Intervention Type: DRUG

Danoprevir (DNV) 100mg tablet administered orally twice daily

Ritonavir

Intervention Type: DRUG

Ritonavir 100mg tablet administered orally twice daily

peginterferon alfa-2a

Intervention Type: DRUG

PegIFN subcutaneous injection at 180 mcg weekly

Ribavirin (RBV)

Intervention Type: DRUG

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

Interventions

Danoprevir

Danoprevir (DNV) 100mg tablet administered orally twice daily

Intervention Type: DRUG

Ritonavir

Ritonavir 100mg tablet administered orally twice daily

Intervention Type: DRUG

peginterferon alfa-2a

PegIFN subcutaneous injection at 180 mcg weekly

Intervention Type: DRUG

Ribavirin (RBV)

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

Intervention Type: DRUG

Other Intervention Names

ASC08; PegIFN; Ribasphere®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huoling Tang, PhD

Role: STUDY_DIRECTOR

Ascletis Pharmaceuticals Co., Ltd.

Other Identifiers

ASC08201502

Identifier Type: -

Identifier Source: org_study_id