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To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 24, 2025 (before its estimated May 14, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jul 14, 2024 to May 14, 2025
    • Study completion date: Jul 14, 2026 to May 14, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 11
    • Start date changed from estimate of Sep 14, 2023 to Sep 28, 2023
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints revised (12)
    • Study description expanded, about 11 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 rare disease, single-arm, open-label,multi-center, non-randomized Phase 2 clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of FCN-159 monotherapy in pediatric patients with refractory/recurrent Langerhans cell histiocytosis (LCH).
Trial Details
NCT Number NCT05997602
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions
(from sponsor)		 Langerhans Cell Histiocytosis, LCH
Related terms Histiocytosis, Langerhans-Cell
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov