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

Официальное название

Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат High volume Plasma Exchange
  High volume Plasma Exchange with minimum 3 sessions on alternate days
• Другое Standard Medical Treatment
  Standard Medical Treatment includes stopping the offending drug,nutrition,injection NAC,Tablet UDCA,steroid in DILI AIH

Первичные конечные точки

• Liver Transplant free survival at the end of 30 days between two groups. [Срок оценки: 30 days]

Вторичные конечные точки (5)

• Changes in arterial lactate levels, on lactate clearance at 0, 3, 5 days [Срок оценки: 0, 3, 5 days]
• Reduction in von Willebrand factor levels, endothelial function, and coagulopathy at 0 and 30 day. [Срок оценки: 0 and 30 day.]
• Changes in the inflammatory milieu, IL6, IL10, and TNF alpha at 0 and 30 day. [Срок оценки: 0 and 30 day.]
• Change in liver-related decompensation events (ascites, HE, variceal bleed) at 0, 3, 5,30, and 90 days. [Срок оценки: 0, 3, 5,30, and 90 days.]
• Change in serum bilirubin and bile acids clearance at 0, 3, 5,30 and 90 days. [Срок оценки: 0, 3, 5,30 and 90 days.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• Institute of Liver & Biliary Sciences (ILBS) — New Delhi

Идентификаторы

NCT: NCT06797011 · ILBS-DILI-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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