NL-OMON31323已完成4 期
PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY - A6281289
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Be at least 18 years of age and at the age of legal consent, and no older than 55 years of age (men and women).;2)Have had a previous TBI (more than 1 year and less than 10 years) prior to the screening visit.;3) Have proven severe GH deficiency as diagnosed by dynamic testing within the last 6 months.
排除标准
- •1) Has any current malignancy except:
- •a. Those >5 years ago without recurrence.
- •b. Excised basal cell carcinoma or squamous cell cancer.
- •2) History of cranial irradiation.
- •3) Growth hormone replacement therapy in the last 12 months.
- •4) History of hypothalamic / pituitary disease which was diagnosed prior to TBI.
- •5) History of dementia unrelated to TBI.
- •6) History of benign intracranial hypertension.
研究者
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