A Phase 2b, Double-Blind, Three Arm, Randomized, Placebo Controlled Trial with Restricted Response Adaptive Randomization Testing the Efficacy and Safety of High Dose Methylprednisolone or Equine Anti-Thymocyte Globulin as Treatment for Acute Liver Failure in Pediatric Patients (Liver Failure)
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)
Sponsor: NIH
Enrolling: Male and Female Patients
IRB Number: AAAU5520
U.S. Govt. ID: NCT04862221
Contact: Transplant Clinical Research Center - TCRC: / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition, as compared to supportive care. Participants will be enrolled while they are hospitalized for acute liver failure, and will continue to be followed for approximately one year. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Steven Lobritto, MD
Do You Qualify?
Is your child between 1 and 18 years old? Yes No
Is your child hospitalized with acute liver failure? Yes No
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For more information, please contact:
Transplant Clinical Research Center - TCRC
tcrcstudyreferral@cumc.columbia.edu

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