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Immunosuppressant

Immune Suppression Therapy for Acute Liver Failure (TRIUMPH Trial)

Phase 2
Recruiting
Led By Valerie L Durkalski-Mauldin, PhD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age is greater than or equal to 1 year and less than 18 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights

TRIUMPH Trial Summary

This trial will help determine if suppressing the immune response with either corticosteroids or equine anti-thymocyte globulin therapy helps improve survival rates for children with acute liver failure.

Who is the study for?
The TRIUMPH study is for children aged 1-17 with acute liver failure, who agree to use contraception if applicable. They must consent to participate and have a specific level of liver injury. Excluded are those with psychiatric disorders, imminent death risk, recent drug use or immunosuppressive therapy, organ transplants, COVID-19 infection, certain infections or vaccinations, allergies to horse dander, pregnancy/breastfeeding women, HIV/AIDS patients, travelers to Hepatitis E regions recently.Check my eligibility
What is being tested?
TRIUMPH evaluates the effectiveness of immunosuppressants (high-dose methylprednisolone or equine anti-thymocyte globulin) versus placebo in improving survival rates among children with life-threatening acute liver failure. This randomized trial will compare three groups: one receiving corticosteroids; another getting equine anti-thymocyte globulin; and a third given placebos.See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk; allergic reactions especially related to horse-derived products; hormonal imbalances due to steroids like weight gain and mood changes; high blood sugar levels; increased appetite; trouble sleeping.

TRIUMPH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 1 and 17 years old.
Select...
I have liver injury with specific blood clotting test results and may or may not have brain function changes due to liver failure.

TRIUMPH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Survival with native liver (SNL)

Side effects data

From 2023 Phase 1 & 2 trial • 307 Patients • NCT02348216
88%
Pyrexia
58%
Hypotension
54%
Anaemia
50%
Decreased appetite
50%
Headache
50%
Fatigue
50%
Neutropenia
50%
Nausea
46%
Vomiting
46%
Hypocalcaemia
42%
Hyponatraemia
38%
Dizziness
38%
Hypoalbuminaemia
33%
Confusional state
33%
White blood cell count decreased
33%
Hypokalaemia
33%
Diarrhoea
33%
Febrile neutropenia
33%
Tachycardia
29%
Chills
29%
Neutrophil count decreased
25%
Hyperglycaemia
25%
Hypophosphataemia
25%
Thrombocytopenia
25%
Encephalopathy
25%
Tremor
25%
Cough
25%
Lymphocyte count decreased
21%
Constipation
21%
Aspartate aminotransferase increased
21%
Alanine aminotransferase increased
21%
Platelet count decreased
21%
Hypoxia
17%
Weight decreased
17%
Upper respiratory tract infection
17%
Hypomagnesaemia
17%
Somnolence
17%
Dyspnoea
17%
Hypertension
17%
Dehydration
17%
Aphasia
17%
Pain in extremity
13%
Pneumonia
13%
Hypogammaglobulinaemia
13%
Leukopenia
13%
Dry mouth
13%
Agitation
13%
Herpes zoster
13%
Myalgia
13%
Anxiety
13%
Abdominal pain
8%
Conjunctivitis
8%
Muscular weakness
8%
Insomnia
8%
Myelodysplastic syndrome
8%
Blood creatinine increased
8%
Hypermagnesaemia
8%
Cardiac arrest
8%
Non-cardiac chest pain
8%
Photophobia
8%
Oedema peripheral
8%
Fall
8%
Electrocardiogram QT prolonged
8%
Dysgeusia
8%
Back pain
8%
Dysuria
8%
Oropharyngeal pain
8%
Pruritus
8%
Disturbance in attention
8%
Abdominal distension
8%
Asthenia
8%
Memory impairment
8%
Vision blurred
8%
Sinus tachycardia
8%
Ventricular arrhythmia
8%
Sinus bradycardia
8%
Arthralgia
8%
Sinusitis
4%
Rectal haemorrhage
4%
Respiratory distress
4%
Swelling
4%
Hyperkalaemia
4%
Depression
4%
Urinary tract infection
4%
Peripheral sensory neuropathy
4%
Rhinitis allergic
4%
Serum ferritin increased
4%
Hemiparesis
4%
Flatulence
4%
Hypernatraemia
4%
Lung infection
4%
Brain injury
4%
Pulmonary embolism
4%
Atrial fibrillation
4%
Pancytopenia
4%
Abdominal pain upper
4%
Pain
4%
Dyspepsia
4%
Neck pain
4%
Catheter site pain
4%
Nasopharyngitis
4%
Clostridium difficile colitis
4%
Local swelling
4%
Blood alkaline phosphatase increased
4%
Disorientation
4%
Restlessness
4%
Mood altered
4%
Hiccups
4%
Pleural effusion
4%
Upper-airway cough syndrome
4%
Night sweats
4%
Hyperhidrosis
4%
Rash
4%
Candida infection
4%
Blood bilirubin increased
4%
Dysarthria
4%
Mental status changes
4%
Urinary incontinence
4%
Tachypnoea
4%
Acidosis
4%
Nasal congestion
4%
Presyncope
4%
Device related sepsis
4%
Delirium
4%
Anal incontinence
4%
Sepsis
4%
Infusion related reaction
4%
Urine output decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 (Pivotal Study): Cohort 2
Retreatment Axicabtagene Ciloleucel: Phase 1
Phase 2 (Safety Management Study): Cohort 3
Phase 2 (Safety Management Study): Cohort 4
Phase 2 (Safety Management Study): Cohort 5
Phase 2 (Safety Management Study): Cohort 6
Phase 2 (Pivotal Study): Cohort 1
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3
Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6

TRIUMPH Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: High-dose methylprednisoloneExperimental Treatment2 Interventions
Intravenous methylprednisolone at an initial dose of 10 mg/kg/day for 3 days, 5 mg/kg/day on day 4.
Group II: Equine anti-thymocyte globulinExperimental Treatment4 Interventions
Intravenous equine anti-thymocyte globulin at a dose of 40 mg/kg/day for 4 days.
Group III: Supportive carePlacebo Group2 Interventions
Supportive care will be administered as determined by the clinical team at participating clinical sites in accordance with their local practices and standards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-dose methylprednisolone
2015
Completed Phase 2
~310
Prednisolone
2005
Completed Phase 4
~2720
Methylprednisolone
2015
Completed Phase 4
~2280
Diphenhydramine
2002
Completed Phase 4
~1140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Corticosteroids and equine anti-thymocyte globulin (ATG) are common treatments for liver injury due to their immunosuppressive properties. Corticosteroids provide broad immunosuppression and anti-inflammatory effects, which help reduce overall immune-mediated damage to liver cells, crucial for preventing further liver injury and promoting healing. Equine ATG specifically targets T-cells, reducing their activity and proliferation. This targeted approach is important because T-cells are key players in the immune response that can exacerbate liver injury. By diminishing T-cell activity, ATG helps decrease the immune-mediated attack on the liver, potentially improving patient outcomes.
Chemical induction of hepatic apoptosis in rodents.Thymoquinone, an Active Constituent of Black Seed Attenuates CCl4 Induced Liver Injury in Mice via Modulation of Antioxidant Enzymes, PTEN, P53 and VEGF Protein.Herbal Compound "Jiedu Huayu" Reduces Liver Injury in Rats via Regulation of IL-2, TLR4, and PCNA Expression Levels.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,381 Previous Clinical Trials
4,315,482 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
261 Previous Clinical Trials
5,189,235 Total Patients Enrolled
Ed Doo, MDStudy DirectorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
14 Previous Clinical Trials
10,019 Total Patients Enrolled

Media Library

Equine anti-thymocyte globulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04862221 — Phase 2
Liver Injury Research Study Groups: Equine anti-thymocyte globulin, High-dose methylprednisolone, Supportive care
Liver Injury Clinical Trial 2023: Equine anti-thymocyte globulin Highlights & Side Effects. Trial Name: NCT04862221 — Phase 2
Equine anti-thymocyte globulin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04862221 — Phase 2
~66 spots leftby Jan 2026