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
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
California
Children's Hospital Los Angeles
Recruiting
Los Angeles
Lucile Packard Children's Hospital
Recruiting
Palo Alto
University of California San Francisco Benioff Children's Hospital
Recruiting
San Francisco
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Connecticut
Yale New Haven Children's Hospital
Recruiting
New Haven
Georgia
Emory Children's Healthcare of Atlanta
Recruiting
Atlanta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Recruiting
Chicago
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Massachusetts
Children's Hospital Boston
Recruiting
Boston
Missouri
The Children's Mercy Hospital
Recruiting
Kansas City
St. Louis Children's Hospital
Recruiting
Saint Louis
North Carolina
Duke University Medical Center - Duke Children's
Recruiting
Durham
New York
The Mount Sinai Medical Center
Recruiting
New York
Ohio
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Pennsylvania
The Children's Hospital of Philadelphia
Recruiting
Philadelphia
Children's Hospital of Pittsburgh
Recruiting
Pittsburgh
Texas
UT Southwestern Medical Center Children's Health
Recruiting
Dallas
Texas Children's Hospital
Recruiting
Houston
Utah
Primary Children's Medical Center
Recruiting
Salt Lake City
Washington
Seattle Children's Hospital
Recruiting
Seattle
Contact Information
Primary
Katie Neighbors, MPH
kneighbors@luriechildrens.org
312-227-4557
Backup
Monica Martino
martmoni@musc.edu
843-876-2616
Time Frame
Start Date: February 9, 2022
Estimated Completion Date: January 2026
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov

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