JPRN-jRCT2031200372进行中（未招募）2 期
Phase 2 study of JR-142 in pediatric patients with growth hormone deficiency
Ryo Ibaraki0 个研究点目标入组 24 人开始时间: 2021年2月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 3age old 至 < 10age old（—）
- 性别
- All
入选标准
- •1) A pediatric patient who has not developed their puberty at the time of the first dose (A pediatric patient who is at Tanner Stage 1)
- •2) A male aged from 3 years to 10 years and 6 months and a female aged from 3 years to 9 years at the time of the first dose
- •3) A pediatric patient with -2.0 or less height SDS for chronological age at the time of screening test and the first dose
排除标准
- •1) A pediatric patient who have previously been treated with GH
- •2) A pediatric patient treated with adrenocortical hormone preparations, anabolic steroid preparations, thyroid hormone preparations, androgen preparations, follicular hormone preparations, luteinizing hormone preparations, Gn-RH derivatives, and IGF-1 preparations that may affect growth promotion within 24 months prior to screening test (for adrenocortical hormone preparations, excluding topical preparations and the use for not more than 1 week consecutively)
- •3) A pediatric patient with diseases causing short stature other than pediatric GHD (endocrine disorders, chromosomal abnormalities, malformation syndromes, bone system diseases, etc.)
- •4) A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)
研究者
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