On September 12, 2016 The HonorHealth Institutional Review Board approved the HepAssure Human Clinical Trial titled:
Phase 2 Active Comparator Clinical Trial of HepAssure™ Medical Food Protocol for Subjects with Detectable Hepatic Fibrosis with Liver Stiffness Measurement (LSM) of 10 kPa to 35 kPa by FibroScan ™ and Aixplorer™ Diagnostic Device.
In order to adequately validate a medical food, human clinical trials are mandated. HepAssure is sponsoring this FDA-approved phase II human clinical trial with Honor Health IRB to investigate the HepAssure Medical Food for patients in cirrhosis with NASH. This anti-fibrotic clinical study will study patients with NASH who demonstrate significant liver fibrosis, demonstrated by fibroscan/MRE scores of 14 kPa - 35 kPa - Liver Fibrosis Stage F4 (cirrhosis) by fibroscan or the equivalent MRE range. The time period of enrollment is up to 12 months, and 24 patients will be selected in total. Patient liver fibrosis staging will be checked in six month intervals to monitor regression of liver fibrosis. Patients will be released when they reach <7.0 kPa (Stage F0-F1) or when they reach the end of 12 months. The purpose of the study is to demonstrate that liver fibrosis generation is triggered when new distinctive nutritional requirements of NASH Patients go unfulfilled. Conversely, by fulfilling the new distinctive nutritional requirements of NASH Patients, the trigger to fibrogenesis may be decreased, stellate cell conversion reduced and the body's natural mechanisms (hepatic collagenase activity) may then resorb hepatic collagen at a fairly constant rate. The intended result of the protocol and clinical trial will be to demonstrate satisfaction of the distinctive nutritional requirements of CLD patients, as shown by decreased liver elastography scores over time.In order to qualify the patient must have stage 4 liver fibrosis (cirrhosis) by NASH, as verified by fibroscan.
If you are interested in sending a patient to be screened to qualify for enrollment in either of the two human clinical trials please go to TheLiverLab.com and download the Physican Referral Form, or download it here.
Then check the box at the bottom of the Physician Referral Form that says: "Please check here if this patient is to be screened for enrollment in the HonorHealth NASH Clinical Trial: _______" and Fax the Referral form to The LiverLab Fibroscan Clinic at 1-888-713-2152 to schedule a fibroscan for your patient.
You can also call The LiverLab at 844-254-8375 (toll free) or go to TheLiverLab.com