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

NCT03020004 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-07-26

Study results available
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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

Interventions

DRUG

Danoprevir

Danoprevir (DNV) 100mg tablet administered orally twice daily

DRUG

Ritonavir

Ritonavir 100mg tablet administered orally twice daily

DRUG

peginterferon alfa-2a

PegIFN subcutaneous injection at 180 mcg weekly

DRUG

Ribavirin (RBV)

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

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
2016-01-31
Primary Completion
2016-11-30
Completion
2017-02-28

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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 NCT03020004 on ClinicalTrials.gov