jRCT2031240562招募中不适用
A Multicenter, Open-label, Single-arm, Phase 3 Study of KK8398 (Infigratinib) in Patients with Achondroplasia (AOBA study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 3age old over 至 18age old not（—）
- 性别
- All
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 analogat 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.
结局指标
主要结局
-
Change from Baseline in annualized height velocity
次要结局
未报告次要终点
研究者
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