CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
BI 201335 +3 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/NCT00984620
NCT00984620Phase 2Completed
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Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

Boehringer Ingelheim·interventional·Posted Sep 25, 2009·Updated Sep 7, 2015

In Brief

A Phase 2 clinical trial evaluating BI 201335, Pegylated Interferon-alpha (IFN), and 1 other intervention for Hepatitis C. Completed, enrolled 160 participants across 28 sites in 6 countries.

Detailed Summary

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustria, Canada, France, Germany, Romania, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.8 years ago

Interventions

BI 201335drug

BI 201335

BI 201335drug

BI 201335

Pegylated Interferon-alpha (IFN)drug

Pegylated Interferon-alpha

Ribavirin (RBV)drug

Ribavirin (RBV)