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Tuberculosis (TB) Immunotherapy Phase 2 Study

NCT ID: NCT01380119

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Keywords

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sputum conversion liver biochemistry weight loss quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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V7

Oral pill containing heat-killed Mycobacterium vaccae

Group Type EXPERIMENTAL

V7

Intervention Type BIOLOGICAL

experimental arm

Placebo pill

Identically appearing placebo pills

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo pill

Interventions

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V7

experimental arm

Intervention Type BIOLOGICAL

placebo

placebo pill

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
* TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
* TB score status at baseline.
* Agreement to participate in the study and to give a sample of blood for lab testing.
* Readily available home or other address where patient can be found.

Exclusion Criteria

* Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
* Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
* Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical University, Ukraine

OTHER

Sponsor Role collaborator

Immunitor USA Inc.

INDUSTRY

Sponsor Role collaborator

Lisichansk Regional Tuberculosis Dispensary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aldar Bourinbaiar, MD/PhD

Role: STUDY_DIRECTOR

Immunitor USA Inc.

Locations

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Lisichansk TB Dispensary

Lisichansk, Luhansk Oblast, Ukraine

Site Status

Countries

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Ukraine

References

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Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Batdelger D, Jirathitikal V, Bourinbaiar AS. Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB. Immunotherapy. 2011 Feb;3(2):181-91. doi: 10.2217/imt.10.96. Epub 2010 Dec 24.

Reference Type BACKGROUND
PMID: 21182457 (View on PubMed)

Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, Frolov VM, Kutsyna GA. Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis. Immunotherapy. 2009 Jul;1(4):549-56. doi: 10.2217/imt.09.25.

Reference Type BACKGROUND
PMID: 20635986 (View on PubMed)

Butov DA, Pashkov YN, Stepanenko AL, Choporova AI, Butova TS, Batdelger D, Jirathitikal V, Bourinbaiar AS, Zaitzeva SI. Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB. J Immune Based Ther Vaccines. 2011 Jan 18;9:3. doi: 10.1186/1476-8518-9-3.

Reference Type BACKGROUND
PMID: 21244690 (View on PubMed)

Efremenko YV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7). Hum Vaccin Immunother. 2013 Sep;9(9):1852-6. doi: 10.4161/hv.25280. Epub 2013 Jun 19.

Reference Type RESULT
PMID: 23782489 (View on PubMed)

Butov DA, Efremenko YV, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled Phase II trial of heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7). Immunotherapy. 2013 Oct;5(10):1047-54. doi: 10.2217/imt.13.110.

Reference Type RESULT
PMID: 24088075 (View on PubMed)

Other Identifiers

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LisichnskRTD

Identifier Type: OTHER

Identifier Source: secondary_id

imm02

Identifier Type: -

Identifier Source: org_study_id