Clinical trial NCT05627648: Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Vocal Fold Scar
Keywords: Hepatocyte Growth Factor
HGF
KP-100LI
KP-100
intracordal injection
Lead sponsor: Kringle Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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, fascial graft, or administration of steroid or hyaluronic acid to vocal cord

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 to prevent conception during the trial period using contraceptive methods

Primary outcomes:
measure: Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: up to 12 weeks
measure: Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period
timeFrame: up to 24 weeks
measure: Changes in Normalized Mucosal Wave Amplitude (NMWA) from baseline to on 4, 8, 12, and 24 weeks of the observational period
timeFrame: up to 24 weeks
measure: Changes in GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale from baseline to on 4, 8, 12, and 24 weeks of the observational period
timeFrame: up to 24 weeks
measure: Evaluation of adverse events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Kamigyo-ku
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
state: Okayama
city: Chiyoda-ku
country: Japan
facility: Nihon University Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Sanno Medical Center
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
Study officials:
affiliation: Kringle Pharma, Inc.
name: Daichika Hayata
role: STUDY_DIRECTOR
References: