EUCTR2009-014457-33-GB进行中（未招募）1 期
An Open Label, Longitudinal Study of the Effects of Subcutaneous Acute and Chronic Pasireotide (SOM230) Therapy on Adrenocorticotrophic Hormone and Tumour Volume in Patients with Nelson's Syndrome. - Pasireotide Therapy in Patients with Nelson's Syndrome Version 1.1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •Inclusion criteria
- •To be verified at Visit one and confirmed at Visit two.
- •Male or female patients aged 18-80 years
- •Signs and symptoms consistent with Nelson’s Syndrome.
- •Biochemistry consistent with Nelsons syndrome: failure to suppress plasma ACTH to less than 200 pg/ml at 2 hours following morning dose of hydrocortisone.
- •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
- •Received any prior or current treatment with a pasireotide or other somatostatin analogue.
- •Requires surgery for recent significant deterioration in visual fields or other neurological signs related to tumour mass.
- •Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphates 2X> upper limit of normal, or total bilirubin 1.5X> upper limit of normal.
- •Abnormal clinical laboratory values considered by the Investigator to be clinically significant and which could affect the interpretation of the study results
- •QTcF interval as measured by ECG >480msecs
- •Any current or prior medical condition that may, in the opinion of the Investigator, interfere with the conduct of the study or evaluation of the results.
- •Female patients who are pregnant or lactating, or of childbearing potential and not practising a medically acceptable method of birth control. Medically acceptable methods include including the oral contraceptive pill, intrauterine devices, mechanical methods (e.g. vaginal diaphragm, vaginal sponge, or condom with permicidal jelly).
- •History of alcohol or drug abuse in the six-month period prior to Visit 1, or who plan to take an investigational drug for another study during this study.
- •History of non-compliance to medical regimes or who are considered potentially unreliable.
- •Pituitary radiotherapy within the last 1 year prior to study entry.
- •Unable to complete the entire study for any reason.
研究者
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