NCT05627648进行中（未招募）3 期
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 11
- 主要终点
- Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
KP-100LI
Active Comparator
Intracordal injection, 20 mcg once per week, 3 weeks
干预措施: KP-100LI (Drug)
Placebo
Placebo Comparator
Intracordal injection, once per week, 3 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period
时间窗: 24 weeks
次要结局
- 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)
- 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)
- Evaluation of adverse events(up to 24 weeks)
- 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)
研究者
研究点 (11)
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