CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 141 enrolled
Drug / intervention
Danoprevir +3 moredrug
Likely dose
Danoprevir 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03020082
NCT03020082Phase 3Completed
CompareCT.gov

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

Ascletis Pharmaceuticals Co., Ltd.·interventional·Posted Jan 13, 2017·Updated Mar 23, 2021

In Brief

A Phase 3 clinical trial evaluating Danoprevir, Ritonavir, and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 141 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 13, 2017
Enrollment StartJun 1, 2016
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.5 years ago

Interventions

Danoprevirdrug

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

Ritonavirdrug

Ritonavir administered orally 100mg BID for 12 weeks;

peginterferon alfa-2adrug

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

RBVdrug

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