Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisone.
- Who it may be relevant to
- Registry conditions: Hepatotoxicity, Idiosyncratic Drug Effect, Prednisone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Proof-of-concept Phase II Study to Evaluate the Efficacy and Safety of Prednisone in the Treatment of Idiosyncratic Hepatotoxicity and Its Mechanistic Pathways Through an Integrative Analysis: the DILI-CORT Clinical Trial
Overview
This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.
Detailed description
This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value, and to assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.
Interventions
- Drug Prednisone
Placebo
Primary outcome measures
- Total bilirubin [Time frame: Through study completation, an average 2 years]
Secondary outcome measures (3)
- Peak alanine aminotransferase level [Time frame: 2 years]
- Aspartate aminotransferase level [Time frame: 2 years]
- International normalized ratio values [Time frame: Through study completation, an average 2 years]
Eligibility criteria
Inclusion criteria
- Female and male patients, aged ≥ 18 years.
- Patients who have been diagnosed with DILI by the expert committee.
- Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg/dL).
- Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.
Exclusion criteria
- No clear DILI diagnosis after an expert committee DILI assessment.
- DILI due to immune-checkpoint inhibitors.
- Presence of active infection as evidenced by positive urine or blood culture.
- Acute liver failure (international normalized ratio (INR) > 1.5 and hepatic encephalopathy).
- Model for End-Stage Liver Disease (MELD) ≥ 30.
- Known hypersensitivity to prednisone or placebo components.
- Pregnant or nursing mothers.
- Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
- Patients already receiving systemic steroids or other immunosuppressants.
- Inability to provide informed consent.
- Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06251232 · DILICORT