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NOT YET RECRUITING
NCT06797011
PHASE2/PHASE3

Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease

Sponsor: Institute of Liver and Biliary Sciences, India

View on ClinicalTrials.gov

Summary

DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease. Asia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.

Official title: Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2025-01-25

Completion Date

2026-01-31

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

High volume Plasma Exchange

High volume Plasma Exchange with minimum 3 sessions on alternate days

OTHER

Standard Medical Treatment

Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH

Locations (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India