Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity — DILICORT  

Hepatotoxicity Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hepatotoxicity

• NCT number: NCT06251232
• Study type: Interventional
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Mª Isabel Lucena, PhD
• Phone: 34952131572
• Email: lucena@uma.es
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Completion date: December 31, 2028