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

Study acronym: DILICORT
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Mar 1, 2024 to May 1, 2024v3
  2. Start date: Feb 1, 2024 to Mar 1, 2024
    • Secondary endpoints revised (3)
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06251232
Lead Sponsor Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions
(from sponsor)		 Hepatotoxicity, Idiosyncratic Drug Effect, Prednisone
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov