Clinical Trial

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

Recruiting Phase 2
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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.
Summary
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-08-15; most recent amendment 2025-01-22.
Status change: Not Yet Recruiting → Recruiting 2023-10-17
Trial Details
NCT Number NCT05997602
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions Langerhans Cell Histiocytosis, LCH
Enrollment 56 participants
Start Date 2023-09-28
Primary Completion 2025-05-14 (estimated)
Study Completion 2027-05-14 (estimated)
Updated on ClinicalTrials.gov 2025-01-24