Clinical Investigation Site Summary: The Institute for Liver Health Treating Nonalcoholic Steatohepatitis (NASH)

Clinical Investigation Site Summary: The Institute for Liver Health Treating Nonalcoholic Steatohepatitis (NASH)

As part of Trialsite News’ ongoing summary of clinical research sites across multiple facets of the clinical trial industry, we have included below a cursory review of The Institute for Liver Health, a clinical investigation site studying the treatment of Nonalcoholic Steatohepatitis (NASH).

Study Sponsor

The Institute for Liver Health, also known as Arizona Liver Health, is one of many clinical research sites studying Elafibranor, an investigational treatment for NASH. Trialsite News covers NASH research ongoing.

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 Prinicipal Investigator

The Key Principal Investigator at Arizona Liver Health is Dr. Richard Manch, FAASLD, FACP, FACG. He joins Arizona Liver Health after spending 18 years developing successful liver transplant programs in Phoenix, AZ. Dr. Manch is board certified in Internal Medicine, Gastroenterology and Transplant Hepatology and has extensive experience as a practicing physician specializing in Hepatology, as well as significant administrative experience.

FDA Findings

Trialsite News researchers sought out the reputation and history of Arizona Liver Health and found they have not once received any FDA Warning Letters or Inspections that we were able to identify.

We have also searched their online presence and found no reviews on their Yelp page, but they have positive reviews on both their Facebook page and their Google listing. This appears to be a positive affirmation for those in the Chandler, Glendale, or Tucson, Arizona, area that may be interested in participating in their clinical trials or have been referred to ALH for treatment.

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