At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 152 enrolled
Drug / intervention
V7 +1 morebiological
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.
Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
In Brief
A Phase 3 clinical trial evaluating V7 and Placebo for Tuberculosis. Completed, enrolled 152 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesMongolia, Ukraine
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartMar 2014
Primary CompletionOct 2018
Study CompletionDec 2018
TodayJul 2026
First PostedNov 7, 2013
Enrollment StartMar 1, 2014
Primary CompletionOct 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.7 years ago
Interventions
V7biological
One pill of V7 once daily for 30 days together with standard of care TB drugs
Placebobiological