The role of TSH in the human immune system, a clinical trial

Erasmusm MC, Rotterdam, The Netherlands0 个研究点目标入组 10 人开始时间: 2009年6月18日最近更新: 2012年3月19日

试验速览

暂无简介。

•Patients must meet the following criteria to be included:
•Have the capacity to understand and willing to sign an informed consent form
•Have been medically treated for primary hypothyroidism for the last 6 months with only adequate thyroxin substitution therapy
•Have medically controlled disease
•T3 and T4 blood levels within the normal range for the past 6 months
•TSH within the normal range for the past 6 months
•TSH>20 mU/l at diagnosis
•Presence of anti TPO antibodies
•Age 20-45 years
•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) no
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded from the study meeting the following criteria:
•Uncontrolled hypothyroidism
•Presence of antibodies to the TSH receptor
•History of M. Graves or thyroiditis
•Presence of struma
•Enlarged tyroid gland measured with ultrasound
•Serious infections in the last 3 months
•Have current symptoms of cardiac disease
•Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
•Clinically relevant abnormal findings during routine physical examination, screening blood samples of hematology, biochemistry, urinanalysis and/or known ECG abnormalities.
•Alcohol abuse
•Known hematologic malignancy
•Known thyroid malignancy
•Other autoimmune disorders than hypothyroidism
•Thymectomy in the medical history
•T cell affecting co-medication

发起方

Erasmusm MC, Rotterdam, The Netherlands