A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Annualized Growth Velocity (GV) in the first year after treatment
研究概览
简要总结
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
详细描述
Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 5-15 years
- •In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
- •Ability to take subcutaneous GH injections nightly
排除标准
- •Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.
研究组 & 干预措施
Arm 1: Growth hormone 0.2 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment
干预措施: Somatropin (Drug)
Arm 2: Growth hormone 0.3 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment
干预措施: Somatropin (Drug)
结局指标
主要结局
Annualized Growth Velocity (GV) in the first year after treatment
时间窗: I year
Height (cm) at 0- month visit; height (cm) at 12-month visit
次要结局
- IGFBP3 - 0,4,8,12 months(12 Months)
- HbA1c - 4,8,12 months(12 Months)
- TSH - 0, 12 months(12 Months)
- IGF1- 0,4,8,12 months(12 Months)
- Total T4 or Free T4 - 0,12 months(12 Months)