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: 9.1 Level: LLT Classification code 10021463 Term: Immunodeficiency with predominant T-cell defect, unspecified
Conditions
Interventions
Trade Name: Thyrogen
Product Name: Thyrogen
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular
Sponsors
Erasmusm MC, Rotterdam, The Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study will be to learn if TSH is able to induce the generation of new T cells by thymopoiesis.;Secondary Objective: Secondary objectives of this study will be to: • Evaluate involvement of TSH in lipid metabolism • Evaluate involvement of TSH in bone metabolism • Evaluate involvement of TSH in CK levels Evaluate involvement of TSH in metabolic pathways (metabolomics) ;Primary end point(s): Primary endpoint consist of a change in thymic output, peripheral cell numbers or ratio’s of peripheral T cell subpopulations in response to treatment with rhTSH. T cell subpopulations will be defined using flow cytometry. Moreover thymic output will be measured using TREC analysis. | — |
Countries
Netherlands
Outcome results
None listed