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Effectiveness of plasma exchange (biological procedure) in autoimmune liver Disease.

Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis. A Pilot Randomized Controlled Study. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081013
Enrollment
50
Registered
2025-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K754- Autoimmune hepatitis

Interventions

Intervention1: Plasma Exchange with Steroid: For plasma Exchange Route: Intravenous Dose: Normal Volume Plex Frequency: Alternate day 3 to 5 sessions Duration: Tentative 10 days For Steroid Route: Ora

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years 2. Acute severe autoimmune hepatitis with MELD more than 24 3. No liver transplant option less than 28 days. 4. ACLF and Non ACLF 5. Auto immune hepatitis: Diagnosis by simplified AIH score more than equals to 6

Exclusion criteria

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 less than 90 by 60 mmhg,HR more than 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 more than 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

Design outcomes

Primary

MeasureTime frame
Reduction in AST,ALT,BilirubinTimepoint: 28 days

Secondary

MeasureTime frame
Liver transplant free survival at 28 daysTimepoint: 28 days;Development of adverse event due to TPE.Timepoint: 28 days;Development of clinical infection during study period.Timepoint: 28 days;Mortality during hospital stay.Timepoint: 28 days;Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present).Timepoint: 28 days;Frequency of decompensation events on follow up period.Timepoint: 28 days;Infections at 28 days.Timepoint: 28 days

Countries

India

Contacts

Public ContactDr Satender Pal Singh

Institute of Liver and Biliary Sciences

ama.satendar@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026