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van CCT (UK)

van CCT (UK)

De rol van het hormoon TSH in het immuunsysteem.

- candidate number6784
- NTR NumberNTR2134
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2009
- Secondary IDsNL28134.078.09 CCMO Erasmus MC Rotterdam
- Public TitleDe rol van het hormoon TSH in het immuunsysteem.
- Scientific TitleThe role of TSH in the human immune system; a clinical trial.
- hypothesisTSH can act on thymocytes to enhance T cell development.
- Healt Condition(s) or Problem(s) studiedImmunodefiencies, T cell development
- Inclusion criteria1. Have the capacity to understand and willingness to sign an informed consent form;
2. Have been medically treated for primary hypothyroidism for the last 6 months with only thyroxin substitution therapy;
3. Adequate treatment with thyroxine;
4. Have medically controlled disease;
5. T3 and T4 blood levels within the normal range for the past 6 months;
6. TSH within the normal range for the past 6 months;
7. TSH>20 mU/l at diagnosis;
8. Presence of anti TPO antibodies;
9. Age 20-45 years.
- Exclusion criteria1. Uncontrolled hypothyroidism;
2. Presence of antibodies to the TSH receptor;
3. History of M. Graves or thyroiditis;
4. Presence of struma;
5. Enlarged tyroid gland measured with ultrasound;
6. Serious infections in the last 3 months;
7. Have current symptoms of cardiac disease;
8. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease;
9. Clinically relevant abnormal findings during routine physical examination, screening blood samples of hematology, biochemistry, urinanalysis and/or known ECG abnormalities;
10. Alcohol abuse;
11. Known hematologic malignancy;
12. Known thyroid malignancy;
13. Other autoimmune disorders than hypothyroidism;
14. Thymectomy in the medical history;
15. T cell affecting co-medication. Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jan-2012
- Target number of participants10
- InterventionsAll subjects will receive rhTSH (Thyrogen“) purchased from Genzyme Europe BV (The Netherlands, Naarden) in a dose of 0.3mg twice weekly intramuscular for 3 weeks.
- Primary outcomePrimary endpoint consist of a change in thymic output, peripheral cell numbers or ratioís 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.
- Secondary outcomeSecondary endpoints are:
1. Lipid metabolism;
2. Bone metabolism;
3. CK levels;
4. Urine metabolites.
- TimepointsVisit 1: Information and screening;
Visit 2: Informed consent;
Visit 3: normal values, start trial medication (T=0d);
Visit 4: trial medication and small blood sample (T=3d);
Visit 5: trial medication blood samples (T=7d);
Visit 6: trial medication and small blood sample (T=10d);
Visit 7: trial medication and blood samples (T=14d);
Visit 8: Trial medication and small blood sample (T=17d);
Visit 9: Blood samples (T=21d);
Visit 10: Control evaluation, without trial medication (T=90d).
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryTSH-R was found to be functionally expressed on thymocytes, able to stimulate T cell development in vitro. Therefore the aim of this study is to investigate if recombinant human TSH (rh-TSH) improves human T-cell development in vivo in a clinical setting, as a proof of concept for use of rh-TSH in a variety of diseases in which naÔve T cell reconstitution is desirable.
10 patients in the age of 20-45 years stably treated for hypothyroidism will be included in this study. Patients will receive 0.3mg rhTSH i.m. twice a week for 3 weeks. Effects on the T cell pool will be measured using TREC and FACS analyses.
- Main changes (audit trail)
- RECORD4-dec-2009 - 18-dec-2009

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