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

• Conditions: All conditions in which a T cell immunodeficiency is present. Examples are genetic immunodeficiencies, chronic viral infections like HIV, after chemotherapy or bone marrow transplantation; MedDRA version: 9.1Level: LLTClassification code 10021463Term: Immunodeficiency with predominant T-cell defect, unspecified

• Registration Number: EUCTR2008-001827-76-NL
• Lead Sponsor: Erasmusm MC, Rotterdam, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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
Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified