NCT05627648

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
10mo left

Started Dec 2022

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2022Feb 2027

First Submitted

Initial submission to the registry

November 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

November 16, 2022

Last Update Submit

December 3, 2025

Conditions

Vocal Fold Scar

Keywords

Hepatocyte Growth FactorHGFKP-100LIKP-100intracordal injection

Outcome Measures

Primary Outcomes (1)

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

    24 weeks

Secondary Outcomes (5)

  • 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

    up to 12 weeks

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

    up to 24 weeks

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

    up to 24 weeks

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

    up to 24 weeks

  • Evaluation of adverse events

    up to 24 weeks

Study Arms (2)

KP-100LI

ACTIVE COMPARATOR

Intracordal injection, 20 mcg once per week, 3 weeks

Drug: KP-100LI

Placebo

PLACEBO COMPARATOR

Intracordal injection, once per week, 3 weeks

Drug: Placebo

Interventions

KP-100LIDRUG

Intracordal injection, 20 mcg once per week, 3 weeks

Also known as: Hepatocyte Growth Factor, HGF
KP-100LI
PlaceboDRUG

Intracordal injection, once per week, 3 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, 814-0001, Japan

RECRUITING

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kamigyō-ku, Kyoto, 602-8566, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Kawasaki Medical School Hospital

Kurashiki, Okayama-ken, 701-0192, Japan

RECRUITING

Nihon University Hospital

Chiyoda-ku, Tokyo, 101-8309, Japan

RECRUITING

Sanno Medical Center

Minato-Ku, Tokyo, 107-0052, Japan

RECRUITING

MeSH Terms

Conditions

Deafness, Autosomal Recessive 39

Interventions

Hepatocyte Growth Factor

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Daichika Hayata

    Kringle Pharma, Inc.

    STUDY DIRECTOR

Central Study Contacts

Daichika Hayata

CONTACT

+81-6-7653-6728hayata@kringle-pharma.com

Hideo Murakami

CONTACT

+81-6-7653-6728h.murakami@kringle-pharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

JP(8)