This is a prospective, controlled, randomized, double-blind, multi-center phase III study comparing the efficacy and safety of the investigational product (IP) which is a plasma volume substitute fluid gelatin, solution for infusion, versus a reference drug in two parallel study groups. The therapeutic indication of the IP is prophylaxis and treatment of imminent or manifest relative or absolute hypovolemia and shock.
According to the study protocol, three medical centers are going to participate in the trial in the Russian Federation, and 72 patients are planned to be enrolled (36 persons per arm). It is planned that the required number of patients will be recruited within the period of 8 months, with the mean enrollment rate 3 patients per site per month. The initial dossier is going to be submitted to the Ministry of Healthcare in August, 2015, while the study is planned to be completed by December, 2016.
The primary objective of the study is to determine if the response rate (RR) obtained with the investigational drug is non-inferior to the RR obtained with the reference drug (based on the alteration of buffer base excess at the time of completion of the surgery) in patients with pelvic or abdominal surgery.
The secondary objectives of the study is to evaluate the efficacy of the study drug treatment as compared to the reference drug, based on its influence on hemodynamic parameters, the need for blood derived products and clinical results, as well as to evaluate the safety of the IP as compared to the reference therapy based on coagulation values, acid-base status, arterial blood gas, clinical and biochemical blood analysis, and incidence rate of adverse events.
This is a full-service clinical project in which OCT will provide full scope regulatory and investigational support including medical writing, site selection, performance of all necessary regulatory activities, making submissions to local ethics committees, execution of CTAs with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics, data management and statistics.
OCT’s in-depth expertise in phase III study conduct counts more than 50 trials in a number of therapeutic areas the majority of which were full-service projects. This includes both local and multinational clinical trials. OCT team will make every effort to provide the highest quality of clinical data to achieve the study objectives within the shortest possible terms!