BridgeMD
New treatment option for Acute Liver Failure
Official title TReatment for ImmUne Mediated PathopHysiology
ClinicalTrials.gov ID: NCT04862221
What this study is testing
What is High-dose methylprednisolone?
High-dose methylprednisolone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute liver failure.
Also referred to as Solu-Medrol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Patient with liver injury of ≤ 6 weeks duration resulting in an international normalization ratio (INR) of ≥ 1.5 or \< 2.0 (not corrected by vitamin...
- 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...
- Females of reproductive potential should not plan on conceiving children during the study and must agree to use a medically accepted form of...
You likely can't join if
- Evidence of active infection with Hepatitis A, B, C, E or evidence of acute herpes simplex virus (HSV) or adenovirus infection
- Travel within the past 3 months to an area highly endemic for Hepatitis E
- Diagnosis of hemophagocytic lymphohistiocytosis (HLH) Note: Patients with a history of consanguinity and/or central nervous system (CNS) dysfunction...
- Aplastic anemia as defined by standardized criteria [1] diagnosed prior to enrollment
- Diagnosis of autoimmune Hepatitis (AIH)
- Diagnosis of acute Wilson disease
See the full eligibility criteria
- Patient with liver injury of ≤ 6 weeks duration resulting in an international normalization ratio (INR) of ≥ 1.5 or \< 2.0 (not corrected by vitamin K) with evidence of hepatic encephalopathy (HE), INR of ≥ 1.5 or \<...
- 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...
- Females of reproductive potential should not plan on conceiving children during the study and must agree to use a medically accepted form of contraception.
- Evidence of active infection with Hepatitis A, B, C, E or evidence of acute herpes simplex virus (HSV) or adenovirus infection
- Travel within the past 3 months to an area highly endemic for Hepatitis E
- Diagnosis of hemophagocytic lymphohistiocytosis (HLH) Note: Patients with a history of consanguinity and/or central nervous system (CNS) dysfunction that is exaggerated compared to the degree of liver dysfunction (as...
- Aplastic anemia as defined by standardized criteria [1] diagnosed prior to enrollment
- Diagnosis of autoimmune Hepatitis (AIH)
- Diagnosis of acute Wilson disease
- Diagnosis of inborn error of metabolism Note: Suspicion of metabolic disease is not an exclusion for entry into the Trial.
- Diagnosis of acute drug or toxin-induced liver injury
- History of recreational drug use within the past 4 weeks
- Therapy with an immunosuppressive agent, including chemotherapy, biological therapies or an experimental drug or device within the past 6 weeks
- Liver injury due to ischemia
- Liver dysfunction diagnosed more than 6 weeks prior to screening
- History of allergy to horse dander
- Sepsis
- Imminent risk of death as judged by the clinical site investigator, including but not limited to; signs of cerebral herniation at the time of enrollment and presence of intractable arterial hypotension
- Solid organ or stem cell transplant recipient
- Pregnant or breast-feeding at the time of proposed study entry
- Clinical AIDS or HIV positive
- History of any form of malignant neoplasm and/or tumors treated within five years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or...
- Received a live-virus vaccine within 4 weeks of study entry
- Patients with positive respiratory secretion testing for respiratory viral infection including SARS-CoV-2, influenza and respiratory syncytial virus only if they also have declining respiratory function
- Psychiatric or addictive disorders that would preclude obtaining informed consent/assent
- Patient is unwilling or unable to adhere with study requirements and procedures
- Currently receiving other experimental therapies
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.