NCT02018172终止不适用
Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Rate of overall treatment adherence
研究概览
简要总结
The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with growth hormone deficiency,
- •Diagnosis of growth hormone deficiency proven by appropriate exploration
- •Size ≤ -2 Standard Deviation (SD) according to the French references
- •Growth velocity in the previous year inferior to the normal for age (-1SD) or < 4cm/year
- •Growth deficiency due to Turner's syndrome
- •Turner's syndrome confirmed by a karyotype
- •Patient's size ≤ -2 SD according to the French references
- •Bone age < 12 years
- •Patient who require a minimum of 18 months of treatment.
排除标准
- •There are no exclusion criteria except the contraindication for Zomacton® 10 mg
研究组 & 干预措施
Zomacton® treatment with Zomajet® Vision X device
干预措施: somatropin (Drug)
结局指标
主要结局
Rate of overall treatment adherence
时间窗: Up to 18 months
Ratio between actual duration of administration and total duration recommended by physician
次要结局
未报告次要终点
研究者
研究点 (1)
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