NCT06797011

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 22, 2025

Last Update Submit

January 27, 2025

Conditions

Drug Induced Liver InjuryChronic Liver Disease

Outcome Measures

Primary Outcomes (1)

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

    30 days

Secondary Outcomes (5)

  • 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.

Study Arms (2)

PLEX with SMT

EXPERIMENTAL

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

Biological: High volume Plasma ExchangeOther: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

Standard treatment.

Other: Standard Medical Treatment

Interventions

High volume Plasma ExchangeBIOLOGICAL

High volume Plasma Exchange with minimum 3 sessions on alternate days

PLEX with SMT
Standard Medical TreatmentOTHER

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

PLEX with SMTStandard Medical Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • UGI bleed, uncontrolled HE
  • Option LTx being considered
  • S. Creatinine \> 2mg/dL
  • DILI ALF
  • Alcoholic Hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Central Study Contacts

Dr Khushboo Yadav, MD

CONTACT

01146300000ky29277@gmail.com

Dr Shasthry SM, DM

CONTACT

01146300000shasthry@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

January 25, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

IN(1)