EUCTR2011-004231-31-NL进行中（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 IGF1 levels has been normalized by long-acting somatostatin analogues - PEQo
Erasmus University Medical Centre Rotterdam0 个研究点开始时间: 2011年10月19日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Acromegalic patients will be recruited in order to ensure 40 evaluable patients will enter the co-treatment period. All subjects should previously be treated with somatostatin analogues during which treatments their IGF-I levels should have normalized.
- •All patients must fulfill the following:
- •At the screening visit,
- •Provision of written informed consent prior to any study related procedures.
- •Male or female aged between 18 and 75 years inclusive
- •The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-1 levels.
- •The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF-1 level above the 60th percentile and below ULN, 28 days after the last injection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients will not be included in the study if he/she:
- •Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry.
- •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
- •Participation in a clinical trail in the last 12 months
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