Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05627648

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Vocal Fold Scar Deafness, Autosomal Recessive 39

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujita Health University Hospital, Toyoake, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

KP-100LI

Drug

Intracordal injection, 20 mcg once per week, 3 weeks

Other names: Hepatocyte Growth Factor, HGF

Placebo

Drug

Intracordal injection, once per week, 3 weeks

Primary outcomes

  1. Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period

    Time frame: 24 weeks

Secondary outcomes

  1. Improvement rate in VHI-10 score from just before the first administration ("baseline" at 0 week) to 4, 8, and 12 weeks of the observational period

    Time frame: up to 12 weeks

  2. Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period

    Time frame: up to 24 weeks

  3. Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period

    Time frame: up to 24 weeks

  4. Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period

    Time frame: up to 24 weeks

  5. Evaluation of adverse events

    Time frame: up to 24 weeks

Sponsors and collaborators

Lead sponsor

Kringle Pharma, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.