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

Phase 2

Not yet recruiting

• Conditions: Drug Induced Liver Injury; Chronic Liver Disease
• Interventions: Biological: High volume Plasma Exchange; Other: Standard Medical Treatment

• Registration Number: NCT06797011
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study Start: 2025-01-25
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Adults aged 18-75 years with previously known or unknown underlying CLD.
2. Diagnosis of DILI based causality of assessment by RECAM.
3. Severe DILI with bilirubin > 12mg/dl or INR>2, S.Bili >5 mg/dl.
4. Consent to participate in the study (based on biopsy/imaging/or clinical criteria).

Exclusion Criteria

1. Active infection
2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).
3. Pregnant or breastfeeding women.
4. HCC or any malignancy
5. UGI bleed, uncontrolled HE
6. Option LTx being considered
7. S. Creatinine > 2mg/dL
8. DILI ALF
9. Alcoholic Hepatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLEX with SMT	High volume Plasma Exchange	High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.
PLEX with SMT	Standard Medical Treatment	High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.
Standard Medical Treatment	Standard Medical Treatment	Standard treatment.

Primary Outcome Measures

Name	Time	Method
Liver Transplant free survival at the end of 30 days between two groups.	30 days

Secondary Outcome Measures

Name	Time	Method
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days	0, 3, 5 days
Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.	0 and 30 day.
Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.	0 and 30 day.
Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.	0, 3, 5,30, and 90 days.
Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.	0, 3, 5,30 and 90 days.

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences (ILBS); 🇮🇳 New Delhi, Delhi, India