Autoimmune Hepatitis Research Studies

Autoimmune hepatitis (AIH) is an inflammatory disease of the liver that results in immune mediated destruction of liver cells that can result in cirrhosis, liver failure, and even death. AIH can present as an acute fulminant event or insidiously over many years, however diagnosis and treatment implementation can be delayed because of complex clinical presentations. Epidemiologic reports have solidified the observation of a female predominance, yet AIH can present in all ages and ethnic populations. Limited data regarding prevalence of AIH has estimated between 50 and 200 cases per 1 million among Caucasians from Western Europe and North America.

Investigator

Craig Lammert, MS, MD

Associate Professor of Medicine

Open Research Studies for Autoimmune Hepatitis

GRACE: Autoimmune Hepatitis Database

The Autoimmune Hepatitis Research Network (AHRN) was developed at Indiana University School of Medicine for studying autoimmune liver disease. The overall objective of the AHRN is to collect information retrospectively and prospectively from AIH patients in order to study both genetic underpinnings and environmental factors important in disease development and outcomes. This collection is called the GRACE Study: Genetic Repository of Autoimmune Liver Disease and Contributing Exposures.

Enrolling: Yes

Principle Investigator: Craig Lammert, MD

Duration: 1 visit

Patient Population: Autoimmune Hepatitis/Pre and Post-Transplant/Overlap

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis

Enrolling: Yes

Principle Investigator: Craig Lammert, MD

Duration: 4 week screening period, 24 week treatment period, 4 week off-treatment safety follow-up period

Patient Population: AIH who have failed standard-of-care treatment, had an incomplete biochemical response to ≥3 months of standard-of-care treatment, or had a disease flare after standard-of-care treatment.

Drug(s): Zetomipzomib

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Rituximab

Enrolling: Yes

Principle Investigator: Craig Lammert, MD

Duration: 12 months

Patient Population: Aged 18 or greater with AIH.

Drug(s): Rituximab

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

AIH Perspectum

Enrolling: No

Principle Investigator: Dr. Craig Lammert

Duration: 18-24 months

Patient Population: Adult patients with AIH who have been undergoing immunosuppressive treatment for 18-24 months.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu

View the study on clinicaltrials.gov

Randomized Crossover Diet Study Comparing Impact of Mediterranean Diet to Western Diet on Fatigue in Autoimmune Hepatitis Patients

Enrolling: No

Principle Investigator: Dr. Craig Lammert

Duration: 2 years

Patient Population: Patients diagnosed with AIH.

Interested in this study? Please contact the clinical liver research team: iuliverr@iu.edu