OCT applied for regulatory approval in Russia and Bulgaria for a phase II study in patients after knee replacement
OCT team has started the application process to obtain the approval for a phase II study to investigate the antithrombotic effect in patients after knee replacement.
The goal of the study is to evaluate the efficacy of the drug candidate in preventing thrombosis.
This is an open label, randomized, international, multi-center phase II study.
OCT will involve regional hubs in Russia and Bulgaria. According to the estimation, around 30 clinics will be included in the study.
The project’s recruitment goal is to 792 patients for the treatment period of 24 months.
Within this project, OCT team is responsible for a scope of services including medical writing, regulatory support, monitoring, pharmacovigilance and final report preparation.