NCT06926491招募中3 期
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients With Achondroplasia (AOBA Study)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 9
- 主要终点
- Change from baseline in annualized height velocity
研究概览
简要总结
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are between 2.5 and 17.5 years old of age at the time of provisional registration. Patients who meet certain criteria in terms of Tanner stage and bone age.
- •Patients who have been diagnosed with achondroplasia through genetic testing.
排除标准
- •Patients who meet the criteria for a certain height determined by age and gender in the "Growth Chart for Patients with Achondroplasia" at the time of the pre-registration examination
- •Patients who have received treatment with r-hGH or a CNP analogue within a certain period prior to the pre-enrollment examination.
- •Patients who have had previous osteotomy or who are scheduled to undergo osteotomy or epiphyseal growth inhibition during the study period. Epiphyseal growth inhibition in which the plate was removed more than 26 weeks prior to the pre-registration examination will not be excluded if the patient has completely healed without sequelae, based on the judgment of the investigator or sub-investigator.
研究组 & 干预措施
KK8398
Experimental
干预措施: KK8398 (Drug)
结局指标
主要结局
Change from baseline in annualized height velocity
时间窗: Pre-dose, Week 52
次要结局
- Height Z-score using growth tables in patients with achondroplasia and the change from baseline(Pre-dose, Week 52)
研究者
研究点 (9)
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