TrialSite News has embarked on a research project unlike any other—inquiring a solid, transparent and patient-centric summary of clinical research sites involved in the clinical trial industry. Below we have provided a review of Fresno Clinical Research Center, a clinical investigation site embarking on a new treatment of Nonalcoholic Steatohepatitis (NASH). You can also view our summary of The Institute for Liver Health in Arizona, which is also involved in the same study of NASH treatments.
Across the nation, 317 research sites are studying Elafibranor, an investigational treatment for NASH. Fresno Clinical Research Center (FCRC) is one of these sites.
FCRC is a privately owned clinical research site that offers leading edge phase 2 and phase 3 clinical trials particularly related to liver and other digestive diseases. The principal investigator, Muhammad Sheikh, MD, FACP, FACG, AGAF, has 18 years’ experience of conducting national and international clinical trials. Over years these clinical trials have benefited hundreds of deserving local valley patients by providing them with state-of the art novel treatment options that were otherwise non-existent in the entire Central California Valley.
Key elements of the FCRC include:
- Central location in Fresno adjacent to the clinical practice site
- State of California, Department of Public Health certified laboratory
- Availability of electronic patient medical records (EPIC)
- In-house capabilities for processing and shipping study samples
- Ability to use Central IRBs designated by the study sponsor
- On-site FibroScan®-a non-invasive bed-side tool to assess liver fibrosis
- Liver Breath Test System
- Wireless temperature monitoring system with alarms and alert notification for ambient, cold and frozen storage for biological samples and drug supply
- Controlled access document storage space and locked cabinets
- Programmable -80° to -20°C freezers
- Centrifuge for on-site processing the blood samples
- EKG machine
- Clinical equipment routinely inspected and dedicated to the conduct of clinical trials
- Collaboration with the state of the art California Imaging Institute, capable of doing liver biopsies, portal pressure measurements, and all sophisticated liver and biliary imaging studies
The sponsor of this study is Genfit, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments.
Study Title, Dates, and Participation
The study is officially titled: “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis.” The start date was in March 2016 and the end date is planned for December 2021. Patients are currently being recruited for this study, and it is estimated to have over 2,000 participants.
Key Principal Investigator
Muhammad Sheikh, MD, FACP, FACG, AGAF is the current principal investigator at FCRC. Dr. Sheikh has served as the founding Chief of the Gastroenterology and Hepatology program at UCSF Fresno. He was instrumental in the creation and accreditation of a new gastroenterology division and fellowship program at UCSF Fresno. He is Professor (emeritus) of Clinical Medicine at UCSF. Prior to moving to Fresno, he was Medical Director for Liver Transplant at the University of California Irvine (UCI) Medical Center.
Dr. Sheikh is board certified in Internal Medicine, Gastroenterology and Clinical Nutrition. In addition, he specializes in hepatology and the management of liver diseases, liver transplant evaluation, and the nutritional support of critically ill patients. Dr. Sheikh is actively involved in clinical research as it relates to hepatitis C, fatty liver, and hepatic encephalopathy.
He completed his residency training at Indiana University and his fellowship training at the University of Louisville in Kentucky and Beth Israel Deaconess Medical Center, Harvard Medical School in Boston.
Dr. Sheikh is listed as one of the best Gastroenterologists in the United States by Consumer Reports and is a fellow of the American College of Physicians (ACP), American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA). He has been selected for “Who’s Who” 2010/2011 edition as a member of North America’s most accomplished Healthcare Professionals. He directs “Valley Gut Club”, a highly prestigious monthly Continuing Medical Education program in the Central California.
Dr. Sheikh is the recipient of “Laureate Award-2012 “from American College of Physicians, Northern California Chapter. He has published extensively in top ranking journals including: The New England Journal of Medicine and Hepatology.
In researching their quality of care and adherence to FDA regulations and standards, TrialSite News researchers did not identify any Warning Letters or Inspections to date.
We have also looked into their online presence, finding that on their Yelp page and Google Listing, they have not yet received any reviews. However, on their Facebook page, they have multiple positive and glowing reviews.
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