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Tuberculosis (TB) Immunotherapy Phase 2 Study

NCT01380119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-10-29

No results posted yet for this study

Summary

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

Conditions

Interventions

BIOLOGICAL

V7

experimental arm

OTHER

placebo

placebo pill

Sponsors & Collaborators

  • National Medical University, Ukraine

    collaborator OTHER

  • Immunitor USA Inc.

    collaborator INDUSTRY

  • Lisichansk Regional Tuberculosis Dispensary

    lead OTHER

Principal Investigators

  • Aldar Bourinbaiar, MD/PhD · Immunitor USA Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT01380119 on ClinicalTrials.gov