drugset / Trial / NCT06251232
Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity
Phase 2
Not yet recruiting
60 enrolled
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2024-05-01
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisone | Other / unclassified | — | Oral |