Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called Therapeutic Plasma Exchange compared to standard high-dose steroid therapy for patients with severe Autoimmune Hepatitis (AIH). AIH is a serious liver disease that can cause significant inflammation, and for some patients, it may lead to liver failure. The trial aims to find out if Plasma Exchange can help patients who do not respond well to steroids and may not be eligible for a liver transplant. Participants in the trial will be divided into two groups: one will receive Plasma Exchange sessions, and the other will receive high doses of steroids. Both groups will be observed for 28 days to see how well their liver function improves.

To be eligible for this trial, participants must be between the ages of 18 to 60 and have been diagnosed with acute severe AIH, which is indicated by a specific scoring system. They should also not be candidates for a liver transplant within the next 28 days. Some individuals will not be eligible, such as those with active infections or severe bleeding, or those who have been on steroids recently. Participants can expect close monitoring throughout the study to assess their liver health, and this trial is not yet open for recruitment, meaning it will start enrolling patients in the future.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-60 years
• • 2. Acute severe autoimmune hepatitis with MELD \>24
• • 3. No liver transplant option \< 28 days.
• • 4. -ACLF + Non ACLF
• • 5. Auto immune hepatitis: Diagnosis by simplified AIH score ≥6
• Exclusion Criteria:
• • 1. Patients with Active sepsis
• • 2. Patients with Active bleeding
• • 3. Patients allergic to FFP and blood products
• • 4. Patients with unstable hemodynamics ( eg:BP\<90/60 mmhg,HR \>100bpm)
• • 5. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
• • 6. Pregnancy related liver failure
• • 7. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
• • 8. Refusal to participate in the study
• • 9. Patients who are eligible to transplant
• • 10. Patients who received steroids or on steroids last 7 days