At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 75 enrolled
Drug / intervention
BI 207127 middle dose +SOC +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.
Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study
In Brief
A Phase 1 clinical trial evaluating BI 207127 middle dose +SOC, BI 207127 high dose+SOC, and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 75 participants across 18 sites in 3 countries.
Detailed Summary
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesFrance, Germany, Switzerland
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionMar 2011
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartMay 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.1 years ago
Interventions
BI 207127 middle dose +SOCdrug
BI 207127 middle dose tid + SOC
BI 207127 high dose+SOCdrug
BI 207127 high dose tid +SOC
Placebo + SOCdrug
Placebo tid +SOC
BI 207127 low dose + SOCdrug
BI 207127 low dose tid + SOC