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Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 6, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 31, 2026 to Jul 31, 2026
    • Site details revised at 8 of 8 sites
    v5
  2. Primary completion date: Jan 31, 2026 to Aug 31, 2026
    • Study completion date: Aug 31, 2026 to Feb 28, 2027
    v4
  3. Primary completion date: Sep 30, 2024 to Jan 31, 2026
    • Study sites: 5 to 8
    • Study completion date: Nov 30, 2025 to Aug 31, 2026
    • Start date: Nov 24, 2022 to Dec 1, 2022
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 5
    • Start date changed from estimate of Nov 18, 2022 to Nov 24, 2022
    • Secondary endpoints: details revised at 4 of 5 entries
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
Trial Details
NCT Number NCT05627648
Lead Sponsor Kringle Pharma, Inc.
Conditions
(from sponsor)		 Vocal Fold Scar
Related terms Deafness, Autosomal Recessive 39
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov