At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 288 enrolled
Drug / intervention
Filibuvir +2 moredrug
Likely dose
Filibuvir 300 mgfrom 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 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects
In Brief
A Phase 2 clinical trial evaluating Filibuvir and Placebo for Hepatitis and Hepatitis C. Completed, enrolled 288 participants across 77 sites in 9 countries.
Detailed Summary
The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis, Hepatitis C
CountriesBelgium, Canada, France, Germany, Hungary, Puerto Rico, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartNov 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedSep 30, 2009
Enrollment StartNov 1, 2009
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.8 years ago
Interventions
Filibuvirdrug
300 mg BID
Filibuvirdrug
600 mg BID
Placebodrug
BID