Trials / Completed
CompletedNCT01977768
TB Immunotherapy Trial With Heat-killed M. Vaccae
Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Immunitor LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V7 | One pill of V7 once daily for 30 days together with standard of care TB drugs |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2018-10-01
- Completion
- 2018-12-01
- First posted
- 2013-11-07
- Last updated
- 2019-07-25
Locations
2 sites across 2 countries: Mongolia, Ukraine
Source: ClinicalTrials.gov record NCT01977768. Inclusion in this directory is not an endorsement.