January 25, 2018
FOR IMMEDIATE RELEASE [Covington, KY ~ January 25, 2018]
HepQuant, LLC, a Greenwood Village, Colorado-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease and CTI Clinical Trial and Consulting Services (CTI) announce the first patient has been enrolled in HepQuant’s HQ-US-SHUNT-1701 study, entitled “The HepQuant SHUNT™ test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology”. The patient populations include those with Alcoholic Hepatitis or Non-Alcoholic Steatohepatitis (NASH), fibrosis stages F3 or F4 (by NASH CRN criteria). The first patient was enrolled at the Texas Liver Institute in San Antonio, TX, in December under Principal Investigator, Dr. Naim Alkhouri.
“HepQuant is proud to have initiated this US multi-center trial focused on the performance of the HepQuant SHUNT Liver Diagnostic Kit in patients with alcoholic hepatitis or advanced fibrotic stages of NASH," says Dr. Gregory Everson, CEO of HepQuant. "Our test is being studied as a measurement of global, or overall, liver function and physiology, quantifying both hepatocyte uptake and portal-systemic shunting. HQ-US-1701 focuses on the changes that occur in the HepQuant SHUNT test prior to and during treatment.”
CTI, an expert in the unique challenges associated with studying subjects with mild to moderate liver disease to end stage acute and chronic liver disease, has extensive experience with NASH populations and is partnering with HepQuant to manage the study across nearly a dozen sites in the US.
“We’re excited to be partnering with HepQuant on this innovative trial,” according to Lynn Fallon, President at CTI. “There is an unmet medical need for non-invasive or minimally-invasive tests to measure global liver function and physiology, and the HepQuant SHUNT could change the way physicians treat patients with liver disease.”
The HepQuant SHUNT™ test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination product. The HepQuant SHUNT test is blood-based, minimally-invasive, and simple to administer; test administration does not require expensive equipment or technology. The test measures hepatocyte function and inflow to the liver from the simultaneous clearances of cholate from systemic and portal circulations. The Test quantifies portal-systemic shunting (SHUNT) and generates a liver disease severity index (DSI).
HepQuant products are investigational combination drug / diagnostic devices and have not yet been evaluated or approved by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA IDE application process. For additional information, please visit our website at www.hepquant.com.
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com