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

Scientific Center for Anti-infectious Drugs (SCAID)

Status and phase: Completed; Phase 3

Conditions: Tuberculosis, MDR

Treatments: Drug: FS-1; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02607449

TP-004 V 5.1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 344 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects suffering from a multidrug-resistant form of pulmonary tuberculosis which is defined by:

  • MDR Tuberculosis confirmed by microbiology test at screening.
  • resistance to isoniazid and rifampicin demonstrated by drug susceptibility test
  • susceptiblity of TB bacteria to fluoroquinolones and aminoglycoside/capreomycin

• all ethnicities, intellectually capable of understanding their own condition and the requirements of the study protocol

• Willing to freely and voluntarily give signed informed consent

• Willing and capable to comply with all requirements of the protocol

Exclusion criteria

• Pregnancy and breast-feeding;
• Patients with decompensated concomitant diseases (cardiovascular, renal, hepatic failure) that may affect the conduct of the study;
• Severe mental disorders;
• Allergy to iodine-containing drugs, hypersensitivity to iodine;
• Intolerance to second-line drugs;
• Epidermomycosis
• Socially maladjusted patients suffering from alcoholism and drug addiction;
• Hypothyroidism;
• Hashimoto's thyroiditis;
• TB treatment for more than two months before the start of the study;
• Not willing to adhere to TB therapy;

Exclusion Criteria during the study:

• at the discretion of the researcher, if the continuation of the study is harmful to the patient;
• side effects related with the study drug
• patient's decision to stop participation in study
• appearance of any exclusion criteria during study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Standard TB treatment+ treatment regiment with FS-1 drug. Study drug was given to the patients orally once per day in dose of 2.5 mg/kg along with other prescribed TB drugs.

Treatment:

Drug: FS-1

B

Placebo Comparator group

Description:

Standard TB treatment + treatment regiment with a placebo. Instead of study drug the placebo was given to the patients orally once per day along with other prescribed TB drugs (in quntity equal to study drug).

Treatment:

Drug: Placebo