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

Last updated: November 9, 2023
Sponsor: Kringle Pharma, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

KP-100LI

Clinical Study ID

NCT05627648
KP-100-FD001
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years to 75 years
  2. Presence of bilateral vocal fold scar or sulcus diagnosed
  3. No other vocal lesion or vocal movement disorder
  4. Voice Handicap Index-10 (VHI-10) score of 11 or higher
  5. No laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascialgraft, or administration of steroid or hyaluronic acid to vocal cord

Exclusion

Exclusion Criteria:

  1. No movement disorders of the vocal fold including paralysis
  2. Airway disease caused by burn
  3. History of malignant tumor
  4. History of allergy to local anesthesia agent
  5. With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs
  6. Serious concomitant disease
  7. Pregnant (including suspected), nursing, wishing to become pregnant, or unable toprevent conception during the trial period using contraceptive methods

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 24, 2022
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Kurume University Hospital

    Kurume, Fukuoka
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kamigyo-ku, Kyoto 602-8566
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi
    Japan

    Active - Recruiting

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama
    Japan

    Active - Recruiting

  • Nihon University Hospital

    Chiyoda-ku, Tokyo
    Japan

    Active - Recruiting

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