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

Chronic Hepatitis C Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020082
• Other study ID #: ASC08201503
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• 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)

• 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, a1 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Danoprevir
Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
• Ritonavir
Ritonavir administered orally 100mg BID for 12 weeks;
• peginterferon alfa-2a
PEG-IFN abdominal or thigh subcutaneous injection, 180µg, once a week for 12 weeks;
• RBV
RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight =75Kg, for 12 weeks.

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