NCT00308464终止2 期
A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 136
- 试验地点
- 36
- 主要终点
- Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
研究概览
简要总结
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
详细描述
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with severe AGHD.
- •Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.
排除标准
- •AGHD patients with uncontrolled pituitary tumor growth.
- •Tumors within 3 mm of the optic chiasm.
- •Patients with diabetes mellitus.
结局指标
主要结局
Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.
次要结局
- Change in PD and glycemic control(At weeks 4 and 7)
- Change in PK concentrations.
- ALT, AST greater than 3.0 times ULN at any visit
- Anti-hGH and anti PHA-794428 antibody production
- Change in body weight(At week 4 and follow-up)
- Injection site reactions
研究者
研究点 (36)
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