21.Aug.2017

OCT to start a phase IIb clinical trial in patients with tuberculosis

This is an international, multicenter, double-blind, placebo-controlled, randomized study to estimate the efficacy, safety and pharmacokinetics of the investigational product in patients with respiratory tuberculosis with bacterial excretion and drug resistance.

It is planned to screen up to 250 subjects who are treatment-naïve or received first-line treatment agents. 150 randomized subjects will be equally allocated to three treatment groups. The total duration of the study treatment is expected to take 8 weeks. The investigational drug will be referred to the background tuberculosis chemotherapy.

The study will involve up to 45 investigational sites and will be conducted in Russia and Belarus.

This clinical trial is a turnkey project for OCT. Our team is responsible for protocol writing, project management, clinical monitoring, and final report preparation. At the moment, OCT team is preparing for submission of a regulatory package to the Ministry of Health of the Republic of Belarus.

Turnkey projects make up about 30% of the company’s clinical trial portfolio. Now, with more than 250 clinical trials successfully completed in Russia, Europe and the US, OCT remains the leading CRO in Russia and across the Eastern Europe.