TReatment for ImmUne Mediated PathopHysiology

Recruiting Phase 2 Interventional Study
Acute Liver Failure Fulminant Hepatic Failure Hepatic Encephalopathy Acute Liver Injury Immune Dysregulation
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
163 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
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About This Trial

TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient with liver injury of ≤ 6 weeks duration resulting in an international normalization ratio (INR) of ≥ 1.5 or \< 2.0 (not corrected by vitamin K) with evidence of hepatic encephalopathy (HE), INR of ≥ 1.5 or \< 2.0 for at least 7 days duration without evidence of HE or …
Contacts

Katie Neighbors, MPH

312-227-4557

kneighbors@luriechildrens.org

CONTACT

Caitlin Schaffner, MPH

843-792-6588

schaffne@musc.edu

CONTACT