Actively Recruiting
TReatment for ImmUne Mediated PathopHysiology
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-14
163
Participants Needed
24
Research Sites
259 weeks
Total Duration
On this page
Sponsors
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
A
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TReatment for ImmUne Mediated PathopHysiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Liver injury duration is 6 weeks or less with specific abnormal blood clotting (INR ≥ 1.5) and/or signs of brain effects from liver failure
- Age is 1 year or older and less than 18 years
- Patient or legal guardian has signed informed consent and assent if applicable
- Females able to have children agree to use medically accepted contraception during the study
You will not qualify if you...
- Active infection with hepatitis A, B, C, or E, herpes simplex virus, or adenovirus
- Travel in past 3 months to high-risk areas for Hepatitis E
- Diagnosis of hemophagocytic lymphohistiocytosis (HLH) or aplastic anemia
- Diagnosis of autoimmune hepatitis, acute Wilson disease, or acute drug/toxin liver injury
- Known metabolic liver errors (unless suspicion only)
- Recreational drug use within past 4 weeks
- Immunosuppressive therapy, chemotherapy, biological or experimental drugs within past 6 weeks
- Liver injury due to ischemia or liver dysfunction diagnosed more than 6 weeks before screening
- Allergy to horse dander
- Sepsis or imminent risk of death
- Organ or stem cell transplant recipient
- Pregnant or breastfeeding
- HIV positive or clinical AIDS
- History of cancer or tumors within 5 years except certain skin or cervical cancers
- Live-virus vaccine within 4 weeks of study entry
- Respiratory viral infection with declining respiratory function
- Psychiatric or addictive disorders preventing consent
- Unwillingness or inability to follow study procedures
- Currently receiving other experimental treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
3
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
4
University of California San Francisco Benioff Children's Hospital
San Francisco, California, United States, 94158
Withdrawn
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Yale New Haven Children's Hospital
New Haven, Connecticut, United States, 06510
Withdrawn
7
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, United States, 30322
Withdrawn
8
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
12
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
13
The Mount Sinai Medical Center
New York, New York, United States, 10029
Withdrawn
14
NYP Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Actively Recruiting
15
Duke University Medical Center - Duke Children's
Durham, North Carolina, United States, 27710
Withdrawn
16
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
17
Cleveland Clinic Children's
Cleveland, Ohio, United States, 44195
Withdrawn
18
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
20
Children's Hospital Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
21
UT Southwestern Medical Center Children's Health
Dallas, Texas, United States, 75235
Actively Recruiting
22
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
23
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112
Withdrawn
24
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
K
Katie Neighbors, MPH
CONTACT
C
Caitlin Schaffner, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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