Autoimmune Hepatitis (AIH) Clinical Trials and Treatments

Autoimmune Hepatitis results from breach of immune tolerance to hepatocyte-specific antigens, leading to autoreactive CD8+ T cells attacking liver cells and autoantibodies against liver cell components. Two main types are recognized: Type 1 AIH (anti-smooth muscle antibodies and/or anti-nuclear antibodies) and Type 2 AIH (anti-liver-kidney-microsomal antibodies). The pathophysiology involves failure of regulatory T cell function, overactivation of effector T cells, and breakdown of immune tolerance.

The most common symptoms of Autoimmune Hepatitis include Fatigue and malaise, Abdominal pain and distension, Jaundice with dark urine and pale stools, Joint pain and morning stiffness, Spider angiomas and palmar erythema in advanced disease, among others. About 16 per 100,000 people worldwide in a 2023 pooled analysis of 37 studies, with wide differences by region and a rise over time. About 1.3 new cases per 100,000 people are diagnosed each year. Symptoms can range from mild to severe and may vary between individuals.

Trial Friend lists all active clinical trials for Autoimmune Hepatitis from ClinicalTrials.gov, with eligibility criteria translated into plain English. Patients can filter by trial phase and recruitment status, search by location, and use the Match Me tool to score trials against their profile. Research in Autoimmune Hepatitis is advancing through optimized immunosuppressive strategies and newer agents that suppress the autoimmune attack while minimizing long-term medication side effects. Traditional approaches combining corticosteroids and azathioprine are being refined, while mycophenolate mofetil and novel immunomodulatory agents offer alternatives with different safety profiles.

As of October 21, 2026, no current FDA drug label names Autoimmune Hepatitis as a condition the drug treats.

The exact cause of Autoimmune Hepatitis is not fully understood. It is not caused by a single gene; inherited variants raise risk, and immune, environmental or other triggers are thought to set it off. Cause unknown; combination of genetic, environmental, and immune factors. Diagnosed by autoantibodies, IgG, and liver biopsy, not gene testing. About 16 per 100,000 people worldwide in a 2023 pooled analysis of 37 studies, with wide differences by region and a rise over time. About 1.3 new cases per 100,000 people are diagnosed each year. Research is ongoing to better understand the disease mechanism.

No single gene test diagnoses Autoimmune Hepatitis. The diagnosis rests on clinical findings and laboratory or imaging results; genetic variants shift risk rather than cause the disease. Cause unknown; combination of genetic, environmental, and immune factors. Diagnosed by autoantibodies, IgG, and liver biopsy, not gene testing.

Some trials collect genetic samples for research or check specific risk markers. The Genetic Testing section of this page shows any tests listed in the NIH Genetic Testing Registry, which for this condition are usually research or risk-marker tests rather than diagnostic ones.

Eligibility for Autoimmune Hepatitis clinical trials depends on factors like age, diagnosis, treatment history, and overall health. Each trial sets its own inclusion and exclusion criteria. Trial Friend translates these requirements from medical language into plain English so patients can review them more easily. The Match Me tool can score your profile against active trials to help identify studies that may be a fit.

Participating in a Autoimmune Hepatitis clinical trial typically involves scheduled visits, medical tests, and close monitoring by a research team. Depending on the study phase, you may receive an investigational treatment, a placebo, or the current standard of care. Trials may last from a few weeks to several years. Study participation is voluntary, and you can withdraw at any time.