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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • High volume Plasma Exchange

    Biological/Vaccine

    High volume Plasma Exchange with minimum 3 sessions on alternate days

  • Standard Medical Treatment

    Other intervention

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: PLEX with SMTExperimental treatment 2 interventions
Group B: Standard Medical TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days

Time frame
0, 3, 5 days
2

Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.

Time frame
0 and 30 day.
3

Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.

Time frame
0 and 30 day.
4

Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days.

Time frame
0, 3, 5,30, and 90 days.

Other outcomes

Sponsors and contacts

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