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
Who is this study for? Children with acute liver failure
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: No
• Patient with liver injury of ≤ 6 weeks duration resulting in an international normalized ratio (INR) of ≥ 1.5 and < 2.0 (not corrected by vitamin K) with evidence of hepatic encephalopathy (HE) or INR ≥ 2.0 without evidence of HE.
• Age is greater than or equal to 1 year and less than 18 years of age.
• Patient or their legally authorized representative(s) (LAR) must consent (and assent, if applicable) to be in the study and must have signed and dated an approved informed consent form which conforms to federal and institutional guidelines.
• Females of reproductive potential should not plan on conceiving children during the study and must agree to use a medically accepted form of contraception.
Children's Hospital Los Angeles
Lucile Packard Children's Hospital
University of California San Francisco Benioff Children's Hospital
Children's Hospital Colorado
Yale New Haven Children's Hospital
Emory Children's Healthcare of Atlanta
Ann & Robert H. Lurie Children's Hospital of Chicago
Riley Hospital for Children
Children's Hospital Boston
The Children's Mercy Hospital
St. Louis Children's Hospital
Duke University Medical Center - Duke Children's
The Mount Sinai Medical Center
Cincinnati Children's Hospital Medical Center
The Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
UT Southwestern Medical Center Children's Health
Texas Children's Hospital
Primary Children's Medical Center
Salt Lake City
Seattle Children's Hospital
Katie Neighbors, MPH
Start Date:February 9, 2022
Estimated Completion Date:January 2026
Target number of participants:160
Experimental: High-dose methylprednisolone
Intravenous methylprednisolone at an initial dose of 10 mg/kg/day for 3 days, 5 mg/kg/day on day 4.
Experimental: Equine anti-thymocyte globulin
Intravenous equine anti-thymocyte globulin at a dose of 40 mg/kg/day for 4 days.
Placebo Comparator: Supportive care
Supportive care will be administered as determined by the clinical team at participating clinical sites in accordance with their local practices and standards.