A Phase 2/3 interventional study of High volume Plasma Exchange and Standard Medical Treatment in Drug Induced Liver Injury and Chronic Liver Disease, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Institute of Liver and Biliary Sciences, India · Phase 2/3, Interventional, and Treatment
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.
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.
78 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 22 are open to participants now.
This study's planned enrollment of 96 is above the median of 80 across 39 interventional studies indexed under Chemical and Drug Induced Liver Injury.
Browse Chemical and Drug Induced Liver Injury studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
High Volume Plex with minimum 3 sessions on alternate days along with Standard treatment.
Biological: High volume Plasma Exchange · Other: Standard Medical Treatment
Standard treatment.
Other: Standard Medical Treatment
High volume Plasma Exchange with minimum 3 sessions on alternate days
Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH
Liver Transplant free survival at the end of 30 days between two groups.
Time frame: 30 days
Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days
Time frame: 0, 3, 5 days
Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day.
Time frame: 0 and 30 day.
Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day.
Time frame: 0 and 30 day.
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.
Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days.
Time frame: 0, 3, 5,30 and 90 days.
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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