No registrations found.
ID
Source
Health condition
immunodeficiencies
T cell development
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary endpoints are:
1. Lipid metabolism;
2. Bone metabolism;
3. CK levels;
4. Urine metabolites.
Background summary
TSH-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 naïve 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.
Study objective
TSH can act on thymocytes to enhance T cell development.
Study design
Visit 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).
Intervention
All subjects will receive rhTSH (ThyrogenÒ) purchased from Genzyme Europe BV (The Netherlands,
Naarden) in a dose of 0.3mg twice weekly intramuscular for 3 weeks.
Kim Weerd, van der
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7044651
k.van.der.weerd@erasmusmc.nl
Kim Weerd, van der
Rotterdam 3015 GE
The Netherlands
+31 (0)10 7044651
k.van.der.weerd@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2017 |
| NTR-old | NTR2134 |
| CCMO | NL28134.078.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33266 |