NCT02607449

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (actual)
• Sponsor: Scientific Center for Anti-infectious Drugs, Kazakhstan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Tuberculosis, MDR

Interventions

Type	Name	Description
DRUG	FS-1	FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.
DRUG	Placebo	Placebo without any active pharmaceutical ingredients

Timeline

• Start date: 2013-12-01
• Primary completion: 2020-08-01
• Completion: 2020-10-01
• First posted: 2015-11-18
• Last updated: 2022-05-24

Locations

6 sites across 2 countries: Kazakhstan, Kyrgyzstan