NCT00151437已完成4 期
A Multi-Center, Open-Label Study For The Compassionate Use Of Pegvisomant In Acromegalic Patients Refractory To Conventional Therapy and For Patients Who Received The Product During The Clinical Development Program.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
研究概览
简要总结
The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies
排除标准
- •ALT/AST>3 times the ULN or have hepatic disease
- •have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor
- •unwilling to self-administer the medication.
结局指标
主要结局
Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize
次要结局
- Pegvisomant demonstrates continued safety and efficacy
研究者
研究点 (6)
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