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Efficacy and safety of prednisone in the treatment of idiosyncratic hepatotoxicity
EU CTIS ID: 2024-513004-33-00
What this study is testing
To assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased TBL, i.e., reduction of the peak of TBL by at least 50% at 14 days or reduction time to normalisation of TBL value. To assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 x 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.
You likely can't join if
- No clear DILI diagnosis after an expert committee DILI assessment.
- Inability to provide informed consent
- Presence of clinically significant comorbid illnesses (by clinician’s criteria) that might impede completion of the study.
- DILI due to immune-checkpoint inhibitors
- Presence of active infection as evidenced by positive urine or blood culture.
- Acute liver failure (INR > 1.5 and hepatic encephalopathy)
See the full eligibility 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 x 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.
- No clear DILI diagnosis after an expert committee DILI assessment.
- Inability to provide informed consent
- Presence of clinically significant comorbid illnesses (by clinician’s criteria) that might impede completion of the study.
- DILI due to immune-checkpoint inhibitors
- Presence of active infection as evidenced by positive urine or blood culture.
- Acute liver failure (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 HIV
- Patients already receiving systemic steroids or other immunosuppressants
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.