Alcoholic liver disease is the leading cause of cirrhosis and liver transplant in the United States. Liver injury caused by alcohol can vary in severity, ranging from simple fat deposits, to a fibrotic “stiffening” of the liver, to irreversible cirrhosis or “scarring” of the liver.
A particularly dangerous manifestation is alcoholic hepatitis – a condition that carries a very high risk of death, even after hospitalization.
Along with the emergence of promising treatment options, Mayo Clinic investigators have conducted numerous clinical trials over the years, informing patient-care decisions across the world. Mayo Clinic, including the Minnesota, Florida, Arizona, Mankato and Eau Claire allied sites, have joined the National Institute of Alcohol Abuse and Alcoholism (NIAAA-NIH)-funded multicentric AlcHepNet consortium.
At present, Mayo Clinic is offering two major clinical trials:
To ensure the success of these studies, alcoholic hepatitis patients as well as healthy controls are welcome to apply; participants can enroll in either or both of these studies. For detailed information, please visit ClinicalTrials.gov (Study IDs NCT03850899 and NCT04072822).
Questions may also be directed to the clinical coordinators:
Furthermore, a team led by Dr. Vijay Shah, Dr. Patrick Kamath and Dr. Douglas Simonetto, has successfully completed an open-label clinical trial to test the safety and efficacy of F-652 (an interleukin-22 fusion protein) on moderate as well as severe alcoholic hepatitis. Encouraged by the results of this phase 2A trial, a much larger, multi-centric trial is in the works, and will begin recruiting soon.
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Sitting (L-R) Harmeet Malhi, M.B.B.S.; Gregory Gores, M.D.; Vijay Shah, M.D. and Meng Yin, Ph.D. Standing (L-R) Mengfei Liu, M.D.; Sheng Cao, M.D.; Enis Kostallari, Ph.D.; Richard Ehmen, M.D.; Micah Scott, Ph.D.; Tejasav Sehrawat, M.B.B.S.; Patrick Kamath, M.D.; Jingbiao Chen, M.B.B.S. and Amy Olofson, R.N. Insert (T-B) Liu Yang, M.B.B.S. (Mayo Clinic, Florida); Hugo Vargas, M.D. (Mayo Clinic, Arizona) and Douglas Simonetto, M.D.