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TB Immunotherapy Trial With Heat-killed M. Vaccae

NCT01977768 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-07-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

V7

One pill of V7 once daily for 30 days together with standard of care TB drugs

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • National Medical University, Ukraine

    collaborator OTHER

  • Immunitor USA Inc.

    collaborator INDUSTRY

  • University of Stellenbosch

    collaborator OTHER

  • Lisichansk Regional Tuberculosis Dispensary

    collaborator OTHER

  • Immunitor LLC

    lead INDUSTRY

Principal Investigators

  • Aldar Bourinbaiar, PhD, MD/PhD · Immunitor LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-10-31
Completion
2018-12-31

Countries

  • Mongolia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977768 on ClinicalTrials.gov