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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Danoprevir, Ritonavir, Peg-IFN,RBV

Participants will receive Ritonavir- boosted Danoprevir 100mg/100mg BID in combination with subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and RBV administered orally 500mg (5 tablets)( body weight \<75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg for 12 weeks.

Group Type EXPERIMENTAL

Danoprevir

Intervention Type DRUG

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

Ritonavir

Intervention Type DRUG

Ritonavir administered orally 100mg BID for 12 weeks;

peginterferon alfa-2a

Intervention Type DRUG

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

RBV

Intervention Type DRUG

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

Interventions

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Danoprevir

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

Intervention Type DRUG

Ritonavir

Ritonavir administered orally 100mg BID for 12 weeks;

Intervention Type DRUG

peginterferon alfa-2a

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

Intervention Type DRUG

RBV

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

Intervention Type DRUG

Other Intervention Names

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ASC08 Peg-IFN Ribasphere®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No