NL-OMON24622尚未招募不适用
Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF-I levels has been normalized by long-acting somatostatin analogues
Dept. of Medicine, Erasmus University MCDepartment of Endocrinology and Metabolism, Leiden University Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •A written informed consent.
- •Male or female age ≥ 18 years. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF1 levels.
- •The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF1 level above the 60th percentile and below 1.2 x ULN, 28 days after the last injection.
排除标准
- •Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
- •If patients have an optimal QoL (100%) assessed by the AcroQoL physical dimension, they cannot enter the study.
- •It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study.
- •Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure.
- •Has already been treated with a somatostatin analogue associated with pegvisomant.
- •Has received a dopamine agonist within 6 weeks prior to study entry.
- •Has been treated with any unlicensed drug within the last 30 days before study entry.
- •Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN).
- •Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study.
- •Has a history of, or known current, problems with alcohol or drug abuse.
- •Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- •Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- •Renal insufficiency, clearance < 60 ml/min
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