PER-018-15招募中未知
A MULTI-CENTER, RANDOMIZED, OPEN-LABEL, PHASE IV STUDY TO INVESTIGATE THE MANAGEMENT OF PASIREOTIDE-INDUCED HYPERGLYCEMIA WITH INCRETIN BASED THERAPY OR INSULIN IN ADULT PATIENTS WITH CUSHING’S DISEASE OR ACROMEGALY.
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 11 人开始时间: 2015年9月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 11
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（—）
- 性别
- All
入选标准
- •Cushing’s disease population
- •-Adult patients (age ≥ 18 y) with confirmed diagnosis of Cushing’s disease
- •(persistent/recurrent or de Novo patients who are not considered candidates
- •for pituitary surgery).
- •Acromegaly population
- •-Adult patients (age ≥ 18 y) with confirmed diagnosis of acromegaly. De Novo
- •patients (with no prior pituitary surgery) can be included if they are not considered candidates for pituitary surgery or have refused surgery.
- •Patients being treated at screening visit with pasireotide should have an elevated FPG > ULN or a diagnosis of diabetes during screening period.
排除标准
- •-Patients who are receiving other medical therapies for Cushing’s disease or acromegaly. All other medical therapies for Cushing’s disease or acromegaly have to be discontinued at least 5 times the half-life of the respective preparation before study entry (start of pasireotide).
- •-Patients who require surgical intervention
- •-Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry
- •-HbA1c > 10 % at screening
- •-Known hypersensitivity to somatostatin analogues
- •-History of liver disease
- •-Cholelithiasis or acute or chronic pancreatitis
- •-Cardiac or repolarization abnormality
- •-Life-threatening autoimmune disorders
- •-Patients who have clinical symptoms of hypothyroidism
- •-Inadequate bone marrow function
研究者
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