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

Institute of Liver and Biliary Sciences, India

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Chronic Liver Disease; Drug Induced Liver Injury

Treatments: Other: Standard Medical Treatment; Biological: High volume Plasma Exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT06797011

ILBS-DILI-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

PLEX with SMT

Experimental group

Description:

High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.

Treatment:

Biological: High volume Plasma Exchange

Other: Standard Medical Treatment

Standard Medical Treatment

Active Comparator group

Description:

Standard treatment.

Treatment:

Other: Standard Medical Treatment