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

NCT06855667 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Not applicable

Started

2025-03-03

Last updated

2025-03-04

Condition(s) studied

Autoimmune Hepatitis

Investigational drug(s) / intervention(s)

Plasma ExchangeSteroidDiet

Plasma Exchange: 3 to 5 sessions alternate day

Steroid: Steroid

Diet: Diet

Study summary

Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of patients with change in AST,ALT,Bilirubin — 28 days

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences (ILBS)	New Delhi	National Capital Territory of Delhi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855667 on ClinicalTrials.gov ↗ ← All trials in India