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FS-1 Drug for Treatment of Multiple Drug-resistant Tuberculosis

2015-11-19 20:43:43 | BioPortfolio

Summary

Drug-resistant tuberculosis is becoming a major problem for the whole humanity, and development of new Anti-TB drugs is of great importance. Since Kazakhstan is a country with the high burden of tuberculosis, The Government of The Republic of Kazakhstan has founded initiative on the development of new Anti-TB drug to treat drug-resistant forms of this infectious disease. JSC "Scientific Center for Anti-infectious Drugs" has developed original drug FS-1 for the treatment of multidrug resistant tuberculosis (MDR-TB).

Description

Phase 3 clinical study of FS-1 drug is a randomized, interventional, multicenter, placebo-controlled (add-on), double-blind and two arms trial.

The study consists of two following phases: treatment phase - 12 months and follow-up phase 12 months. It is planned to recruit 480 patients with verified MDR-TB diagnosis.

All data will be compiled in an Electronic Data Capture System with further statistical analysis according to approved Statistical Analytical Plan.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Tuberculosis

Intervention

FS-1, Placebo

Location

National Center of Phthisiatry
Bishkek
Kyrgyzstan

Status

Recruiting

Source

Scientific Center for Anti-infectious Drugs, Kazakhstan

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-11-19T20:43:43-0500

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