At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 241 enrolled
Drug / intervention
TMC207 +1 moredrug
Likely dose
TMC207 400mgfrom 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 II, Open-label Trial With TMC207 as Part of a Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Subjects With Sputum Smear-positive Pulmonary Infection With MDR-TB.
In Brief
A Phase 2 clinical trial evaluating TMC207 and Background Regimen (BR) for MDR-TB for Tuberculosis. Completed, enrolled 241 participants across 27 sites in 12 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesChina, Estonia, Kenya, Latvia, Peru, Philippines, Russia, South Africa, South Korea, Thailand, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartSep 2009
Primary CompletionMar 2011
Study CompletionJan 2013
TodayJul 2026
First PostedJun 1, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2011
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.1 years ago
Interventions
TMC207drug
TMC207 400mg once daily for 2 weeks then 200mg three times a week for 22 weeks.
Background Regimen (BR) for MDR-TBdrug
Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as specified in the protocol for up to 96 weeks.