At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Ribavirin +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.
A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection
In Brief
A Phase 2 clinical trial evaluating Ribavirin, BI 207127 high dose, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 35 participants across 19 sites in 4 countries.
Detailed Summary
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesGermany, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedApr 2013
Primary CompletionOct 2014
TodayJul 2026
First PostedApr 12, 2013
Enrollment StartApr 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.2 years ago
Interventions
Ribavirindrug
24 Weeks
BI 207127 high dosedrug
24 Weeks
Faldaprevirdrug
24 Weeks
Ribavirindrug
24 Weeks
BI 207127 low dosedrug
24 Weeks
Faldaprevirdrug
24 Weeks