HepQuant to Sponsor its First Clinical Study
Utilizing 3 Investigational Device Exemptions (IDEs) in Clinical Study of Patients with Alcoholic Hepatitis, NASH F3, NASH F4
DENVER (Sep. 28, 2017) — 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, today announced that is sponsoring its first clinical study. It will use its HepQuant SHUNT™ Liver Diagnostic Test to measure liver disease severity and treatment effects in approximately 72 subjects with advanced liver disease. The subject population will include those with Non-Alcoholic Steatohepatitis (“NASH”) F3 or F4, and Alcoholic Hepatitis.
Founder and Chief Executive Officer Dr. Greg T. Everson said, “The first objective of this study, the first sponsored by HepQuant, will be to evaluate the HepQuant Disease Severity Index (“DSI”) for measuring liver disease severity and treatment effects.”
“In cases of Alcoholic Hepatitis, tests like HepQuant SHUNT may be important because liver disease severity impacts short-term (weeks or months) survival. NASH is a very serious liver disease and its prevalence has increased significantly since the 1990s. Unfortunately, NASH can progress to cirrhosis and is associated with liver cancer. Measuring liver disease severity in NASH can clarify the patient’s prognosis and monitor treatment effects.”
“Furthermore, this study allows us to collect safety and effectiveness data that will be required to support a premarket application to the FDA,” Everson said.
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.
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