CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 310 enrolled
Drug / intervention
PegIFN/RBV +5 moredrug
Likely dose
Not stated in 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/NCT01399619
NCT01399619Phase 3Completed
CompareCT.gov

Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

Boehringer Ingelheim·interventional·Posted Jul 22, 2011·Updated Aug 29, 2016

In Brief

A Phase 3 clinical trial evaluating PegIFN/RBV, BI201335, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 310 participants across 71 sites in 8 countries.

Detailed Summary

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBrazil, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 22, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.9 years ago

Interventions

PegIFN/RBVdrug

PegIFN/RBV for 24 or 48w

PegIFN/RBVdrug

PegIFN/RBV for 24 or 48w

BI201335drug

BI201335 for 12w

BI201335 24Wdrug

BI201335 for 24w

PegIFN/RBVdrug

PegIFN/RBV for 24 or 48w

Bi 201335drug

BI 201335 for 24 w