Humedics GmbH has announced the start of a clinical phase III trial. The main goal of this study is the early identification of low-risk patients after partial liver resection by the LiMAx test and improvements in patient management based on test results.
After the initiation of first study centers in January, first patients already have been enrolled in Berlin and Jena.
The trial with the short title 'Fast-track LiveR' is a prospective, randomized, controlled, multi-centric, phase III study for the early identification of low-risk patients after partial liver resection with the LiMAx test.
A major goal is to demonstrate the benefit for the patient and the impact on clinical thinking related to a different postoperative management (fast-track procedure) with immediate transfer of patients with good liver function from the recovery room to general ward.
Erwin de Buijzer, Managing Director of Humedics GmbH, commented the trial start: “The start of our phase III study is a milestone on the way to the approval of our LiMAx test and thus for the further company development of Humedics. We want to provide physicians with a new diagnostic procedure to enable a reliable liver function analysis prior and after liver surgery, to adapt therapy options respectively and thereby contributing to optimized and cost efficient healthcare. After we received the official approval for conducting the study from the German Federal Institute for Drugs and Medical Devices (BundesinstitutfürArzneimittel und Medizinprodukte, BfArM) and the positive vote of the ethics committee end of 2012 we were able to start immediately with the initiation of the first study centers early this year. We are very excited that Berlin and Jena already have enrolled the first patients within such a short time span.”
Chief Investigator PD Dr. Martin Stockmann from Charité - Universitätsmedizin Berlin at the Campus Virchow Hospital, Dept. of General, Visceral and Graft Surgery, added “Liver surgery with a partial removal of the liver implies a general risk of postoperative complications including severe complications like liver failure. So far, an analysis of the remaining liver function was not possible. The LiMAx test of Humedics has the potential to address this medical need and thus to optimize and individualize patient management. In the clinical practice this may result, for example, in decision-making on the basis of liver function analysis if a patient needs to be further treated in an Intensive Care Unit or if he can be transferred to general ward.”
Prof. Dr. UtzSettmacher, Director of the Dept. of General and Visceral Surgery and responsible for the Fast-track LiveR study center at the Jena University Hospital, said: “With the LiMAx test we are able to directly determine the liver function and thus to assess much better the outcome of liver surgery. This is new and both - clinician and patient - benefit from the test. We are very pleased to take part in this important trial and also about the fact that we have been able to include patients within the first days after study initiation.”