Clinical Trials for Alcoholic Liver Disease

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:

1. The Use of G-CSF or Anakinra plus Zinc in patients with Alcoholic Hepatitis: Phase 2B, multi-center trial in which participants will be randomly selected to be treated with either of two new promising therapies – granulocyte-colony stimulating factor (G-CSF) or Anakinra plus zinc, or to current standard of care arm with corticosteroid treatment.
2. A Study to Establish an Alcoholic Hepatitis Network: Observational, multicenter trial where non-invasive biospecimens such as blood samples will be collected from participants and used, after removal of all personal identifiers, to aid in new discoveries for alcoholic hepatitis.

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:

• Amy Olofson (olofson.amy@mayo.edu)
• Janelle Worthington (worthington.janelle@mayo.edu)

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.

Meet other people talking about alcohol & non-alcohol related liver disease on Mayo Clinic Connect. Join the conversation, share experiences, ask questions, and discover your support network...

• Liver transplant support group
• Liver biopsy

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.