NCT06797011

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Design Single-center, non-blinded, parallel group, randomized controlled trial. Allocation ratio between two groups: 1:1. Study population: Adults aged 18-75 years with previously known or unknown underlying CLD Diagnosis of DILI-based causality of assessment by RECAM. Severe DILI with bilirubin \> 12mg/dl or INR\>2, S.Bili \>5 mg/dl Consent to participate in the study (based on biopsy, imaging or clinical criteria). Study design: RCT Study period: 1 year Sample size: 96 Intervention: Patients after screening for all exclusion criteria will be randomized into either the standard treatment group or the plasma exchange group. Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid.

Conditions

• Drug Induced Liver Injury
• Chronic Liver Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-25
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: India