CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Stop trial intervention for boceprevir, PEG-IFN and RBVdrug
Likely dose
Stop trial intervention for boceprevir, PEG-IFN and RBV 100 IUfrom 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/NCT02060058
NCT02060058Phase 3Completed

Boceprevir-based Triple Therapy to Rescue HCV Genotype 1/HBV Dually Infected Patients Refractory to Peginterferon Plus Ribavirin Combination Therapy

Kaohsiung Medical University Chung-Ho Memorial Hospital·interventional·Posted Feb 11, 2014·Updated Mar 13, 2018

In Brief

A Phase 3 clinical trial evaluating Stop trial intervention for boceprevir, PEG-IFN and RBV for Hepatitis C, Chronic. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The aim of this study is to explore the efficacy and safety of boceprevir -based triple therapy to rescue HCV genotype 1 (HCV GT1)/HBV dually infected patients refractory to previous peginterferon (PEG-IFN) plus ribavirin (RBV) combination therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2014
Enrollment StartNov 1, 2013
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.4 years ago

Interventions

Stop trial intervention for boceprevir, PEG-IFN and RBVdrug

Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped. Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.