25.Jul.2013

OCT enrolled first patient in Phase III deep venous thrombosis study

OCT is happy to announce the start of enrollment in an international deep venous thrombosis study sponsored by OCT's return client - a big European pharmaceutical company.

OCT is happy to announce the start of enrolment in clinical trial in an international deep venous thrombosis study. The sponsor of this trial, a big European pharmaceutical company, is OCTs return client. OCT successfully completed several trials for this client and now we are excited to start enrollment in this new one. We will be recruiting 180 patients at 11 sites in Russia within 8 months. The study will last through 2014 and will include patients diagnosed with deep vein thrombosis aged 18 years or older. The central European sites will be managed by OCT’s partner CRO company. We have conducted several trials together with this CRO-partner.

This is a phase III clinical study investigating the efficacy and safety of low molecular weight heparin treatment. Deep vein thrombosis usually affects larger veins such as the ones in the thighs and lower legs. A blood clot forms in large veins as a result of a recent surgery, immobility, genetic predisposition, trauma to the lower leg and other factors. A blood clot in a deep vein can break off and travel through the bloodstream causing the risk of blocking the blood flow in lungs or other organs especially the heart. Thromboembolic complications – particularly pulmonary embolia – are a major cause of morbidity and mortality in patients with deep vein thrombosis.

All clinical sites participating in the trial have been initiated and are ready to screen and enroll patients. The first patient has already been randomized at one of the sites in Russia, which is expected to be the top-enrolling country in this trial. At the moment, OCT clinical team assigned to the project are fully focused on motivating investigators to enroll patients.

This is a full-service support clinical project, including project management, site selection, clinical monitoring, warehousing, study materials purchase and other logistics assistance, safety management, regulatory activities within the clinical trial approval and export/import licenses obtainment, final report preparation, investigator’s meeting organization, among other services. In addition OCT provides clinical data management and final statistical report preparation services in this study. The leading international laboratory will be used for biosamples assessment.