Status: Not yet recruiting
Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity
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.
Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUpdated: Apr 5, 2024
Eligibility criteria
Female and male patients, aged ≥ 18 years. [+3]
No clear DILI diagnosis after an expert committee DILI assessment. [+10]