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Search / Trial NCT06698991

Daily Versus Alternate Day Plasma Exchange in Wilson Disease With Acute Liver Failure in Children

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Nov 19, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different schedules for a treatment called plasma exchange in children with Wilson disease who are experiencing acute liver failure. Wilson disease is a condition that causes copper to build up in the body, which can lead to serious health issues, including liver failure. The trial will compare daily plasma exchange treatment to alternate-day treatment to see which schedule is more effective at removing excess copper from the blood and improving patient outcomes.

To be eligible for this trial, children aged 3 to 18 years must have Wilson disease and meet certain health criteria, such as having a specific score indicating the severity of their condition. However, children with severe brain swelling or other serious health issues won't be included. Participants can expect to receive plasma exchange treatments, which help quickly remove harmful substances from the blood. This trial aims to find the best way to help these children, potentially improving their chances of recovery and overall health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Wilson disease with New Wilson Index of ≥ 11 and INR ≥ 2.5
  • 2. Children aged 3 years to 18 years
  • Exclusion Criteria:
  • 1. Grade 3 or grade 4 hepatic encephalopathy
  • 2. Septic shock
  • 3. Disseminated intravascular coagulation
  • 4. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine \>0.5 mcg/kg/min)
  • 5. Any severe cardio-pulmonary pre-existing disease

About Institute Of Liver And Biliary Sciences, India

The Institute of Liver and Biliary Sciences (ILBS) in India is a premier research and healthcare institution dedicated to the advancement of knowledge and treatment in liver, biliary, and related diseases. As a clinical trial sponsor, ILBS is committed to conducting innovative and ethically-driven research to improve patient outcomes and enhance therapeutic options in hepatology. The institute fosters collaboration among multidisciplinary teams of clinicians, researchers, and healthcare professionals, ensuring rigorous scientific methodologies and adherence to regulatory standards. Through its focus on translational research, ILBS aims to bridge the gap between laboratory discoveries and clinical applications, ultimately contributing to the global understanding and management of liver diseases.

Locations

New Delhi, Delhi, India

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported