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Danazol for Treatment of Cytopenias in Patients With Cirrhosis

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Nov 2025 to Aug 1, 2027
    • Start date changed from estimate of May 2023 to Aug 1, 2024
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Aug 2022 to Nov 2025
    • Start date: May 1, 2021 to May 2023
    • Study completion date: Oct 2023 to Nov 2025
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase II pilot study designed to assess the safety and efficacy of danazol for treatment of cytopenias in patients with CPC A/B cirrhosis. Subjects with or without telomere mutations and/or shortened telomeres will be treated with danazol 600 mg per day by mouth for a duration of 24 months. The goal will be to treat a total of 10 patients.
Trial Details
NCT Number NCT04873102
Lead Sponsor University of Southern California
Conditions
(from sponsor)		 Cirrhosis, Liver, Cytopenia
Related terms Cytopenia, Liver Cirrhosis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov