NL-OMON39522已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
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
研究者
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