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

NCT03020082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2021-03-23

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Danoprevir

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

DRUG

Ritonavir

Ritonavir administered orally 100mg BID for 12 weeks;

DRUG

peginterferon alfa-2a

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

DRUG

RBV

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

Sponsors & Collaborators

  • Ascletis Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Huoling Tang, PhD · Ascletis Pharmaceuticals Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020082 on ClinicalTrials.gov