Efficacy and safety of prednisone in the treatment of idiosyncratic hepatotoxicity

Phase 1

• Conditions: Hepatotoxicity; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2024-513004-33-00
• Lead Sponsor: Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified