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

NCT06855667 | Not Yet Recruiting

• 1 other identifier: ILBS-AIH-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with change in AST,ALT,Bilirubin

  28 days

Secondary Outcomes (7)

• Liver transplant free survival at 28 days.

  28 days

• Development of adverse event due to TPE

  28 days

• Number of patients with development of clinical infection during study period

  28 days

• Mortality during hospital stay

  28 days

• Change in grade of HE, grade of ascites (both ascites and HE if present).

  28 days

Study Arms (2)

Plasma Exchange

EXPERIMENTAL

3 to 5 sessions +Steroids

Biological: Plasma Exchange; Drug: Steroid

Standard Medical Treatment

ACTIVE COMPARATOR

Steroids + Nutrition

Drug: Steroid; Dietary Supplement: Diet

Interventions

Plasma Exchange BIOLOGICAL

3 to 5 sessions alternate day

Plasma Exchange

Steroid DRUG

Steroid

Plasma Exchange; Standard Medical Treatment

Diet DIETARY_SUPPLEMENT

Diet

Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Acute severe autoimmune hepatitis with MELD \>24
• No liver transplant option \< 28 days.
• ACLF + Non ACLF
• Auto immune hepatitis: Diagnosis by simplified AIH score ≥6

You may not qualify if:

• Patients with Active sepsis
• Patients with Active bleeding
• Patients allergic to FFP and blood products
• Patients with unstable hemodynamics ( eg:BP\<90/60 mmhg,HR \>100bpm)
• Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
• Pregnancy related liver failure
• 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)
• Refusal to participate in the study
• Patients who are eligible to transplant
• Patients who received steroids or on steroids last 7 days

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Plasma Exchange; Steroids; Diet

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Fused-Ring Compounds; Polycyclic Compounds; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Dr J.Gnana Kavitha, MD

CONTACT

09717270640; drkavitha777@gmail.com

Dr Satender Pal Singh, DM

CONTACT

01146300000; ama.satender@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 4, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

IN (1)