CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 719 enrolled
Drug / intervention
BI 201335 NA 240 mg QD / LI +13 moredrug
Likely dose
BI 201335 NA 240 mg QD / LIfrom 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/NCT00774397
NCT00774397Phase 2Completed
CompareCT.gov

Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)

Boehringer Ingelheim·interventional·Posted Oct 17, 2008·Updated Nov 16, 2015

In Brief

A Phase 2 clinical trial evaluating BI 201335 NA 240 mg QD / LI, PegIFN/RBV, and 4 other interventions for Hepatitis C, Chronic. Completed, enrolled 719 participants across 100 sites in 15 countries.

Detailed Summary

The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesArgentina, Australia, Austria, Canada, Czechia, France, Germany, Netherlands, Portugal, Romania, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartOct 1, 2008
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.7 years ago

Interventions

BI 201335 NA 240 mg QD / LIdrug

240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

BI 201335 NA 120mg QD / LIdrug

120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

BI 201335 NA 240 mg QDdrug

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

BI 201335 NA 240 mg QDdrug

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

BI 201335 NA 240 mg BIDdrug

240mg BI 201335 NA (Faldaprevir) twice, 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks

BI 201335 NA 240 mg QDdrug

240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks

PegIFN/RBVdrug

PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks

Placebodrug

Placebo