Humedics starts LiMAx phase III trial on liver function analysis for severe liver surgery
First patients being included directly after study initiation 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 (Bundesinstitut für Arzneimittel 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. Utz Settmacher, 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.”
Fast-track LiveR Trial
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. The LiMAx test determines the actual liver function in real-time. The test includes the application of the diagnostic investigational medicinal product, 13C-Methacetin solution for infusion and a breath test involving the use of Humedics’ FLIP device for measurement and analysis. 120 patients with different types of liver tumors and designated for open liver surgery are to be included in the study. Two study arms have been set up; each planned to enroll 60 patients. The LiMAx group is subject to a perioperative patient management according to the fast-track procedure. This includes a pre- and postsurgical analysis of the liver function with the LiMAx test. In the control group the perioperative patient management is performed according to current clinical standards. The trial will be conducted at different study centers in Germany and is expected to be completed by the end of 2013.
Based in Berlin, Germany, Humedics GmbH is specialised in rapid and accurate liver function measurement using LiMAx®, an innovative technology for analysing exhaled air. The LiMAx® test provides physicians with a method for quantitatively assessing an individual patient’s liver function capacity within minutes. This enables physicians to select treatment strategies and follow disease progression based on up-to-date knowledge of the functional health of the liver.
Current applications, which have already been published in prestigious medical journals, include liver function diagnosis before and after liver transplantation, surgical planning for liver surgery (such as assessing how much liver tissue can be removed without increasing the risk of acute liver failure), and assessment of liver diseases such as fibrosis and cirrhosis. At present, more than 20 studies regarding new indications are being conducted. These include diagnosing and staging of chronic liver diseases such as non-alcoholic steatohepatitis (NASH), as well as selecting, monitoring and managing different oncology treatment options.
These studies, initiated by researchers, have already provided evidence of further potential for the LiMAx® tests. The LiMAx® test is in routine clinical use at more than 30 leading university hospitals in Europe. So far, more than 20,000 LiMAx® tests have been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.