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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).
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
National Center of Phthisiatry
Scientific Center for Anti-infectious Drugs, Kazakhstan
Published on BioPortfolio: 2015-11-19T20:43:43-0500
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