At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 249 enrolled
Drug / intervention
No treatmentdrug
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 Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection
In Brief
A Phase 3 clinical trial evaluating No treatment for Hepatitis C. Completed, enrolled 249 participants across 48 sites in 7 countries.
Detailed Summary
The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesBelgium, Canada, France, Germany, Poland, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJul 2011
Primary CompletionJan 2016
TodayJul 2026
First PostedMay 6, 2011
Enrollment StartJul 4, 2011
Primary CompletionJan 5, 2016
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.2 years ago
Interventions
No treatmentdrug
No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.