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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020004
• Other study ID #: ASC08201502
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: January 2017
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a-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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Danoprevir
Danoprevir (DNV) 100mg tablet administered orally twice daily
• Ritonavir
Ritonavir 100mg tablet administered orally twice daily
• peginterferon alfa-2a
PegIFN subcutaneous injection at 180 mcg weekly
• Ribavirin (RBV)
Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/=75 kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment	SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration	24 weeks