NCT04326374Unknown3 期
The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in China
Visen Pharmaceuticals (Shanghai) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Annualized height velocity(AHV) at Week 52
研究概览
简要总结
This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).
详细描述
Not Provided
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 17 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, aged of 3 years and below 17 years;
- •Impaired HT defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS≤-2.0) according to the Chinese 2005 standard；
- •Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay. Bone age (BA) at least 6 months less than the chronological age；
- •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)；
- •Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is 8 years old or above).
排除标准
- •Children with a body weight below 12 kg；
- •Prior exposure to recombinant hGH or IGF-1 therapy；
- •Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast dye recommended) at Screening
- •Children born SGA (birth weight ≤10th percentile for gestational age according to the Chinese reference)；
- •Children with psychosocial dwarfism；
- •Children with idiopathic short stature；
- •Other causes of short stature such as coeliac disease, hypothyroidism, or rickets；
- •History or presence of malignant disease; any evidence of present tumor growth;
- •Subjects with diabetes mellitus；
- •Closed epiphyses；
- •Major medical conditions and/or presence of contraindication to hGH treatment；
- •Participation in any other trial of an investigational agent within 3 months prior to Screening.
研究组 & 干预措施
Daily hGH
Active Comparator
Daily hGH will be self-administered or injected by parents once daily. The dose will be adjusted based on subject's weight.
The treatment will continue 52 weeks.
干预措施: daily hGH (Drug)
TransCon hGH
Experimental
TransCon hGH will be self-administered or injected by parents once weekly. The dose will be adjusted based on subject's weight.
The treatment will continue 52 weeks.
干预措施: TransCon hGH (Drug)
结局指标
主要结局
Annualized height velocity(AHV) at Week 52
时间窗: 52 Weeks
Annualized height velocity at Week 52 for weekly TransCon hGH treatment and the daily hGH treatment groups
次要结局
- AHV and the change from baseline over 52 weeks at each visit(52 Weeks)
- Height SDS and the change from baseline over 52 weeks(52 weeks)
- The plasma concentration(52 weeks)
- Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline over 52 weeks at each visit(52 weeks)
- The percentage of participants achieving IGF-1 SDS 0 to +2.0(52 weeks)
- Incidence of Treatment-Emergent Adverse Events(52 weeks)
研究者
研究点 (1)
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