EUCTR2007-001746-40-HU
进行中（未招募）
不适用
A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD)
Ambrx, Inc., USA0 个研究点目标入组 45 人2007年4月2日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Growth Hormone Deficiency
- 发起方
- Ambrx, Inc., USA
- 入组人数
- 45
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Young adults, male or female, age 18 to 30 years, with growth
- •hormone deficiency of childhood onset whom have completed growth
- •(and in the investigators opinion have achieved their final height);
- •2\. hGH level below the predetermined cut\-off value in one of the dynamic
- •endocrine testing (If there are more than two tests performed all should
- •have peak hGH levels below predetermined cut\-off values):
- •a. If Insulin Tolerance Test, the peak hGH value must be below 3
- •b. If Arginine\-GHRH Test, the peak hGH value must be below 5
- •ng/ml. This test is however not acceptable in patients with
- •GHD of hypothalamic origin (e.g. patients having received
排除标准
- •1\. Evidence of growth of pituitary adenoma or other intracranial tumor
- •within the last 12 months which has to be confirmed by computer
- •tomography (CT) or magnetic resonance imaging (MRI) scan (with
- •contrast) within 3 months prior to study entry. Patients with primary
- •growth hormone deficiency are exempt from this requirement
- •2\. History of malignancy other than I) cranial tumor or leukemia causing
- •GHD or II) fully treated basal cell carcinoma;
- •3\. Subjects presenting with any clinically significant ECG abnormality,
- •including a corrected QT interval (QTc) \> 450 msec for males or a
- •corrected QT interval (QTc) \> 470 msec for females using Bazett’s
结局指标
主要结局
未指定
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