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

Tuberculosis, MDR Clinical Trial

Official title: Randomized, Placebo-controlled Study of Safety and Therapeutic Efficacy of the Drug FS-1 in the Oral Dosage Form in Drug-resistant Pulmonary Tuberculosis

Status Completed

Clinical Trial 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).

Clinical Trial 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 - 6 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. ;

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, MDR
• Tuberculosis, Multidrug-Resistant

• NCT number: NCT02607449
• Study type: Interventional
• Source: Scientific Center for Anti-infectious Drugs, Kazakhstan
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Completion date: October 2020