PREDNISONE for Hepatotoxicity

Inclusion criteria

• {"criterion_text":"- Female and male patients, aged ≥ 18 years"}
• {"criterion_text":"- Patients who have been diagnosed with DILI by the expert committee"}
• {"criterion_text":"- Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 x ULN and serum TBL ≥ 2.5 mg/dL."}
• {"criterion_text":"- 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

• {"criterion_text":"- No clear DILI diagnosis after an expert committee DILI assessment."}
• {"criterion_text":"- Inability to provide informed consent"}
• {"criterion_text":"- Presence of clinically significant comorbid illnesses (by clinician’s criteria) that might impede completion of the study."}
• {"criterion_text":"- DILI due to immune-checkpoint inhibitors"}
• {"criterion_text":"- Presence of active infection as evidenced by positive urine or blood culture."}
• {"criterion_text":"- Acute liver failure (INR > 1.5 and hepatic encephalopathy)"}
• {"criterion_text":"- Model for End-Stage Liver Disease (MELD) ≥ 30."}
• {"criterion_text":"- Known hypersensitivity to prednisone or placebo components"}
• {"criterion_text":"- Pregnant or nursing mothers"}
• {"criterion_text":"- Co-existing infection with hepatitis C, hepatitis B, or HIV"}
• {"criterion_text":"- Patients already receiving systemic steroids or other immunosuppressants"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14.","definition_or_measurement_approach":"Proportion of patients achieving ≥50% decrease from peak total bilirubin (TBL) measured at day 14."}
• {"endpoint_text":"- Time (days) to TBL value return to normal.","definition_or_measurement_approach":"Time in days from baseline to normalization of total bilirubin (TBL) value."}
• {"endpoint_text":"- Proportion of AEs, SAEs, fatality, and proportion of patients with premature termination due to AEs.","definition_or_measurement_approach":"Proportion and counts of adverse events (AEs), serious adverse events (SAEs), deaths (fatality), and proportion of patients who discontinue prematurely due to AEs."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients that achieve a decrease of at least 50% of the peak value in ALT, AST and INR at day 7.","definition_or_measurement_approach":"Proportion of patients achieving ≥50% decrease from peak values in ALT, AST and INR at day 7."}
• {"endpoint_text":"- Time (days) for the ALT, AST and INR values return to normal.","definition_or_measurement_approach":"Time in days from baseline to normalization of ALT, AST and INR."}
• {"endpoint_text":"- Proportion of patients that develop acute liver failure, need for liver transplantation or liver related death at day 28.","definition_or_measurement_approach":"Proportion of patients reaching composite outcome of acute liver failure, requirement for liver transplantation, or liver-related death by day 28."}
• {"endpoint_text":"- Score changes in SF-36 quality of life validated questionnaire performed at visit 1 (day 1, start of treatment) and at visit 6 (day 35, end of treatment).","definition_or_measurement_approach":"Change in SF-36 questionnaire scores between visit 1 (day 1) and visit 6 (day 35)."}

Spain

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

496

Number Of Sites

15

Number Of Participants

60

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain