163 Participants Needed

Immune Suppression Therapy for Acute Liver Failure

(TRIUMPH Trial)

Recruiting at 18 trial locations
KN
KM
MM
CS
Overseen ByCaitlin Schaffner, MPH
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments that reduce immune activity in children with severe, unexplained liver failure. The treatments work by calming the immune system to prevent it from harming the liver.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on immunosuppressive agents, chemotherapy, biological therapies, or experimental drugs, you may need to stop, as these are part of the exclusion criteria.

Is immune suppression therapy generally safe for humans?

Prednisolone, a common immune suppression drug, has been used in various liver conditions and is known to improve symptoms, but it can have serious side effects, especially at high doses. In children with autoimmune hepatitis, high doses of prednisone can lead to significant adverse effects, and alternative treatments like cyclosporine are sometimes used to avoid these issues.12345

How does the drug Equine anti-thymocyte globulin and Prednisolone differ from other treatments for acute liver failure?

This drug combination is unique because it uses Equine anti-thymocyte globulin (eATG) to suppress the immune system, which is typically used in transplant patients to prevent rejection, and Prednisolone, a steroid that reduces inflammation and immune response. This approach is novel for acute liver failure, as there are no standard treatments specifically targeting immune suppression for this condition.36789

What data supports the effectiveness of the drug Equine anti-thymocyte globulin (eATG) for treating acute liver failure?

Research shows that Equine anti-thymocyte globulin (eATG) has been used successfully in kidney transplant patients to prolong graft survival and reduce rejection episodes. This suggests it may help in managing immune responses in other transplant scenarios, like liver transplants.67101112

Who Is on the Research Team?

Alonso, Estella M., MD | Lurie Children's

Estella Alonso, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

VL

Valerie L Durkalski-Mauldin, PhD

Principal Investigator

Medical University of South Carolina

ED

Ed Doo, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

AS

Averell Sherker, MD

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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
I am between 1 and 17 years old.
See 1 more

Exclusion Criteria

You have traveled to an area with a lot of cases of Hepatitis E in the last 3 months.
You have an active infection with certain viruses like Hepatitis or herpes.
You have tested positive for the virus that causes COVID-19.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose methylprednisolone or equine anti-thymocyte globulin or supportive care alone for 4 days, followed by a taper from days 5 to 42

6 weeks
Daily visits during initial 4 days, followed by regular visits during taper

Follow-up

Participants are monitored for safety and effectiveness after treatment with visits at 1 week, 2 weeks, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months

12 months
7 visits (in-person or virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Equine anti-thymocyte globulin
  • Methylprednisolone
  • Prednisolone
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: High-dose methylprednisoloneExperimental Treatment2 Interventions
Group II: Equine anti-thymocyte globulinExperimental Treatment4 Interventions
Group III: Supportive carePlacebo Group2 Interventions

Equine anti-thymocyte globulin is already approved in United States, Canada for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as ATGAM for:
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as ATGAM for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials
2,513
Recruited
4,366,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials
275
Recruited
5,182,000+

Published Research Related to This Trial

A four-and-a-half-year-old boy with progressive familial intrahepatic cholestasis underwent living-donor liver transplantation and initially received standard immunosuppressive therapy, but developed acute cellular rejection that did not respond to steroid treatments.
The introduction of muromonab-CD3 therapy after repeated steroid failure led to a significant recovery in liver function tests and overall health, indicating its potential effectiveness in treating severe graft rejection in pediatric liver transplant patients.
Muromonab-CD3 for the successful treatment of early chronic rejection after pediatric liver transplantation: report of a case.Hori, T., Nguyen, JH., Uemoto, S.[2021]
In a study involving 50 transplant recipients, the combination of equine antithymocyte globulin (ATG) with azathioprine and prednisone significantly prolonged allograft survival and reduced the severity of rejection episodes, with only three kidneys lost to rejection.
The treatment with ATG did not lead to serious hematologic or systemic side effects, and the rate of infections was comparable to other transplant studies, suggesting it is a safe option for immunosuppression in transplant patients.
Clinical evaluation of equine antithymocyte globulin in recipients of renal allografts: Analysis of survival, renal function, rejection, histocompatibility, and complications.Diethelm, AG., Aldrete, JS., Shaw, JF., et al.[2019]
In a study of 49 patients who underwent their first liver transplantation for hepatitis C, those who received anti-thymocyte globulin (ATG) during the induction phase had a significantly lower rate of HCV recurrence (26.9% vs 73.9%) compared to those receiving standard therapy.
Despite the reduced HCV recurrence, the use of ATG did not impact overall patient survival rates at 1 and 2 years, nor did it significantly affect the rates of acute cellular rejection, infections, or neoplasms, although there was a higher incidence of fungal infections in the ATG group.
Impact of anti-thymocyte globulin during immunosuppression induction in patients with hepatitis C after liver transplantation.Garcia-Saenz-de-Sicilia, M., Olivera-Martinez, MA., Grant, WJ., et al.[2021]

Citations

Muromonab-CD3 for the successful treatment of early chronic rejection after pediatric liver transplantation: report of a case. [2021]
Clinical evaluation of equine antithymocyte globulin in recipients of renal allografts: Analysis of survival, renal function, rejection, histocompatibility, and complications. [2019]
Impact of anti-thymocyte globulin during immunosuppression induction in patients with hepatitis C after liver transplantation. [2021]
Treatment strategies in autoimmune hepatitis. [2019]
Preliminary results of a "prope" tolerogenic regimen with thymoglobulin pretreatment and hepatitis C virus recurrence in liver transplantation. [2019]
Short-term cyclosporine induces a remission of autoimmune hepatitis in children. [2019]
Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine Versus Cyclosporine: A Randomized Trial. [2021]
Drug choices in autoimmune hepatitis: part A--Steroids. [2013]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Hepatoprotectors containing phospholipids decrease the immunosuppressive effect of prednisolone in rats with experimental toxic hepatitis]. [2016]
Immunosuppressive therapy in chronic liver disease. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Anti-thymocyte globulin for the treatment of acute cellular rejection following liver transplantation. [2022]
Outcome of induction immunosuppression for liver transplantation comparing anti-thymocyte globulin, daclizumab, and corticosteroid. [2021]
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