Tissue Biomarker for Pegvisomant Action
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Effect of Pegvisomant on Colon Tissue p53 Expression
研究概览
简要总结
Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acromegaly established on the basis of symptoms and signs at presentation, evidence of a pituitary adenoma on MRI, elevated serum concentrations of IGF1 (>1.3 X ULN), and inadequate GH suppression (>0.4 ng/mL) following OGTT
- •Candidates to receive pegvisomant therapy following pituitary adenoma surgery, or intolerant of other medical treatments or had not undergone previous therapy
- •Normal LFTs before treatment
- •Dynamic testing of the pituitary axis and, if applicable, appropriate hormone replacement
排除标准
- •Treatment with a long-acting SRL within 12 weeks before enrollment
- •Presence of a macroadenoma with visual field defects as a result of chiasmatic compression
- •Clinically significant hepatic abnormalities and/or AST or ALT >3 X ULN on screening
- •Known hypersensitivity to any of the test materials or related compounds
- •History of, or known current, problems with alcohol or drug abuse
- •Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude
研究组 & 干预措施
Pegvisomant
干预措施: Pegvisomant (Drug)
结局指标
主要结局
Effect of Pegvisomant on Colon Tissue p53 Expression
时间窗: 8 weeks
Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant
次要结局
未报告次要终点
研究者
Shlomo Melmed, MD
Executive Vice President, Academic Affairs
Cedars-Sinai Medical Center