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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Active infection

Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P/F ratio).

Pregnant or breastfeeding women.

HCC or any malignancy

Trial design

Treatments tested in this trial

  • High volume Plasma Exchange
  • Standard Medical Treatment

Treatment groups

96 Participants
are divided into 2 treatment groups