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Immune Suppression Therapy for Acute Liver Failure (TRIUMPH Trial)
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.
TRIUMPH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRIUMPH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRIUMPH Trial Design
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Who is running the clinical trial?
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- 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.I am willing and able to follow the study's requirements.I have not received a live-virus vaccine in the last 4 weeks.I was diagnosed with liver dysfunction over 6 weeks ago.You have had an allergic reaction to horses.You are at high risk of dying soon, as determined by the doctor at the clinical site. This could be because of certain serious medical conditions like uncontrollable low blood pressure or signs of severe brain swelling.I haven't taken any immunosuppressive drugs, including chemotherapy, in the last 6 weeks.I have liver damage caused by a drug or toxin.I haven't had cancer, except for skin or cervical cancer, in the last 5 years.I have been diagnosed with acute Wilson disease.I have been diagnosed with HLH and am waiting for genetic test results.I have been diagnosed with a metabolic disorder.I am between 1 and 17 years old.You have used recreational drugs in the past 4 weeks.I have received a solid organ or stem cell transplant.I have been diagnosed with aplastic anemia before joining this study.I have liver damage caused by reduced blood flow.I am HIV positive or have been diagnosed with AIDS.I currently have sepsis.You are currently taking other experimental treatments.I have been diagnosed with autoimmune hepatitis.I have liver injury with specific blood clotting test results and may or may not have brain function changes due to liver failure.
- Group 1: Equine anti-thymocyte globulin
- Group 2: High-dose methylprednisolone
- Group 3: Supportive care
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the eligibility criteria for participation in this medical experiment?
"This trial is looking for 160 subjects suffering from hepatic coma and aged between 1 year old to 18 years. To be eligible, patients must meet a set of criteria such as presenting an international normalized ratio (INR) of 1.5 to 2 without evidence of hepatic encephalopathy or INR greater than or equal to 2 with HE present. Additionally, female candidates hoping to conceive during the study are not accepted; instead they should use medically approved contraception methods. Moreover, those taking part in this experiment have to sign an informed consent form that adheres with federal regulations and institutional protocols."
Have prior experiments revealed any beneficial outcomes of administering High-dose methylprednisolone?
"Karolinska Institutet first started investigating the effects of high-dose methylprednisolone back in 2002, and presently there are 1,092 completed clinical trials. Additionally, 352 studies that require patient recruitment are still active – primarily located around Pittsburgh."
What is the capacity of participants in this research endeavor?
"Affirmative. The patient search was initiated on February 9th 2022, as outlined by clinicaltrials.gov's data set, and is currently in motion. 160 individuals are sought from 20 different medical facilities for the trial."
Does this experiment still have open vacancies?
"Currently, this clinical trial is onboarding patients. The original post went up on February 9th 2022 and was updated as recently as October 28th 2022 according to the data hosted by clinicaltrials.gov."
Has the FDA sanctioned High-dose methylprednisolone for medical use?
"High-dose methylprednisolone scores a 2 due to limited clinical data supporting its safety, but no studies confirming efficacy."
How many study locations are currently implementing this trial?
"This study is taking place in a plethora of medical centres, including Children's Hospital of Pittsburgh (Pittsburgh), University of California San Francisco Benioff Children's Hospital (San Francisco) and The Children’s Mercy Hospital (Kansas City). There are 20 additional research locations as well."
To what pathologies is high-dose methylprednisolone commonly prescribed?
"High-dose methylprednisolone has been used to manage pain, general surgical procedures and ulcerative colitis."
Are participants aged 25 or older eligible to join this experiment?
"Eligible participants for this medical investigation must be between 1 and 18 years old. As of now, 154 trials have been developed specifically to investigate treatments in the younger age bracket while 397 are dedicated to individuals aged over 65."
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