NL-OMON30806已完成3 期
Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant 40 to 120 mg per week (administered via subcutaneous route once or twice a week) in acromegalic patients failing to respond to lanreotide Autogel 120 mg - Study 727 Combi
Ipsen Pharmaceuticals0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •1. Male or female aged between 18 and 75 years inclusive.
- •2. The patient must have had documentation supporting the diagnosis of
- •acromegaly, including elevated GH and/or IGF-1 levels.
- •3. The patient is treated with pegvisomant, because of IGF-1 level remaining
- •above ULN when treated with somatostatin analogue, on a daily basis for at
- •least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1
- •level above ULN after treatment with pegvisomant 30 mg per day,
- •OR the patient is treated with lanreotide Autogel or octreotide LAR for at
- •least 6 months including the last 3 months at the highest marketed dose, and
- •has a serum IGF-1 level above ULN, 28 days after the last injection.
- •AT THE END OF THE RUN-IN PERIOD
- •4. The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1
- •level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L
- •(assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel
- •5. The patient is diabetic and has a serum IGF-1 level above 1.2 x ULN, 28
- •days after the 3rd injection of lanreotide Autogel 120 mg.
排除标准
- •1. The patient has undergone pituitary surgery or radiotherapy within 6 months
- •prior to study entry.
- •2. It is anticipated that the patient will receive pituitary surgery or radiotherapy
- •during the study.
- •3. The patient has a history of hypersensitivity to lanreotide or pegvisomant or
- •drugs with a similar chemical structure.
- •4.The patient has already been treated with a somatostatin analogue associated
- •with a GH antagonist.
- •5. The patient has received a dopamine agonist within 6 weeks prior to study
- •6.The patient has abnormal hepatic function at study entry (defined as AST,
- •ALT, GGT, AP, PT or total bilirubin above 2 x ULN).
研究者
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