Revival of autochthonous adrenocortical stem cells in autoimmune Addison’s disease (RoSA) - Revival of Stem cells in Addison's disease (RoSA)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 12 人开始时间: 2010年3月18日最近更新: 2012年12月3日

适应症

试验速览

暂无简介。

•- Subjects between 16 and 65 years of age
•- Adrenocortical failure, as judged by a basal cortisol of less than 100nmol/l or peak ACTH-stimulated cortisol response of less than 300nmol/l that was established a minimum of 1 year previously and persists at run-in assessments
•- Elevation of ACTH at diagnosis or during testing in the run-in phase of the study
•- Positive adrenal antibodies at baseline or recorded during illness
•- Normal or atrophic adrenal glands on CT scan
•- Willingness to travel to Newcastle CRF for study
•- Willingness to attend education sessions about indications for parenteral glucocorticoid administration and technique of administration
•- Female participants of child-bearing age will be willing to take acceptable contraception during study, and for 3 months following last synacthen dose
•Are the trial subjects under 18? yes
•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) no
•F.1.3.1 Number of subjects for this age range

•- Significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy
•- Pregnancy, breast feeding or plan for pregnancy within 9 months
•- Known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.)
•- Known hypersensitivity or allergy to Synacthen, synacthen depot or zinc salts

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust