EUCTR2009-016640-39-NL进行中（未招募）1 期
Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers. - ELATE
Radboud University Nijmegen Medical Centre0 个研究点目标入组 44 人开始时间: 2009年12月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
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
- •- 18-70 years of age
- •- isolated polycystic liver disease, defined as at least 20 liver cysts
- •- total liver volume must be at least 2500 mL
- •- informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •ADPKD patients
- •Use of oral anticonceptives or estrogen suppletion
- •Females who are pregnant or breast-feeding
- •Intervention within three months before baseline
- •Patients with a kidney transplant
- •History of chronic pulmonary disease associated with functional limitation
- •History of severe cardiac disease
- •History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •Symptomatic gallstones (octreotide decreases gall bladder volume)
- •Hypercholesterolemia or hypertriglyceridaemia not controlled by lipid lowering therapy
- •Granulocytopenia or thrombocytopenia
- •Infection with hepatitis B, hepatitis C, HIV, TBC (in medical history)
- •Mental illness that interferes with the patient ability to comply with the protocol
- •Drug or alcohol abuse within one year of baseline
- •Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin
- •Known hypersensitivity to everolimus
研究者
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