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Study to Determine Optimal Dose and Evaluate Safety, Tolerability, and Pharmacokinetics of Progerinin in Patients With Hutchinson-Gilford Progeria Syndrome (HGPS)

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Lead sponsor: PRG Science & Technology Co., Ltd. to PRG Science & Technology Co., Ltd. Show 6 more changesShow less
    • Primary endpoints: details revised at 2 of 23 entries
    • Trial completed
    • Study completion date changed from estimate of Mar 2026 to Apr 30, 2026
    • Primary completion date changed from estimate of Mar 2026 to Mar 30, 2026
    • Eligibility criteria expanded, about 27 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Recruiting to Active, Not Recruitingv2 Show 5 more changesShow less
    • Enrollment target: estimated 16 to confirmed 10
    • Primary and study completion dates: Dec 2025 to Mar 2026
    • Start date changed from estimate of Jan 2025 to Jan 13, 2025
    • Eligibility criteria shortened, about 10 words
    • Site details revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Researchers will compare treatment with progerinin plus lonafarnib vs lonafarnib alone to assess optimal dosing, safety, tolerability, and pharmacokinetics in patients with Hutchinson-Gilford Progeria Syndrome (HGPS). Subjects in the randomized study arms will continue to take the standard of care (SOC), lonafarnib, and will be randomized to either take SOC alone or in combination with progerinin.
Trial Details
NCT Number NCT06775041
Lead Sponsor PRG Science & Technology Co., Ltd.
Conditions
(from sponsor)		 Hutchinson-Gilford Progeria Syndrome
Related terms Progeria
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov