NCT06007417尚未招募3 期
The Efficacy and Safety of Once-weekly PEG-somatropin (GenSci004) in Treatment-naive Children With Growth Hormone Deficiency: A Randomized, Open-label, Parallel-group, Active-Controlled, Non-inferiority Phase 3 Study (ELEVATE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
详细描述
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
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
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prepubertal children with GHD in Tanner Stage 1
- •Baseline HT at least -2.0 SD below the mean HT for CA and sex (HT SDS ≤ 2.0).
- •Body mass index (BMI) within ±2.0 SD of the mean BMI for BA and sex.
- •Growth hormone stimulation tests: ≤10 ng/mL
- •Baseline IGF 1 level of at least 1.0 SD below the mean IGF 1 level standardized for age and sex (IGF 1 SDS ≤-1.0)
- •Normal 46 XX karyotype for girls.
- •Children with multiple hormonal deficiencies must be on stable replacement therapy for other hypothalamo-pituitary axes for at least 3 months
- •Written, signed informed consent of the parent(s) or legal guardian(s) of the participant and written assent of the participant
排除标准
- •Prior exposure to rhGH, long-acting growth hormones, or IGF 1 therapy.
- •Major medical conditions or presence of contraindication to human growth hormone (hGH) treatment
- •Participation in any other trial of an investigational agent within 3 months prior to Screening.
- •Any reason per investigator's discretion
研究组 & 干预措施
GenSci004
Experimental
干预措施: GenSci004 (Drug)
Genotropin
Active Comparator
干预措施: Genotropin (Drug)
结局指标
主要结局
Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups
时间窗: 52 weeks
Measured in centimeter per year (cm/year)
次要结局
- Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups(104 weeks)
研究者
研究点 (1)
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