At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 58 enrolled
Drug / intervention
boceprevir +2 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 Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)
In Brief
A Phase 4 clinical trial evaluating boceprevir, PegIFN-2b, and 1 other intervention for Hepatitis C. Completed, enrolled 58 participants.
Detailed Summary
This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedDec 24, 2012
Enrollment StartFeb 6, 2013
Primary CompletionNov 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.5 years ago
Interventions
boceprevirdrug
PegIFN-2bbiological
RBVdrug