To evaluate possible changes in immune profiles and platelet function after start of a TPO-RA.
ID
Source
Brief title
Condition
- Platelet disorders
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
monitor B and T cell profiles and changes in platelet function and reactivity
in adult patients with ITP who are treated with eltrombopag.
Secondary outcome
nvt
Background summary
It has been suggested that prolonged use of TPO-receptor agonists (TPO-RA) can
result in immune tolerance induction in patients with ITP. However, little is
known about the effect of this kind of immune modulation on B- and T-cell
profiles in ITP. Furthermore, the use of TPO-RA is associated with an increased
rate of thromboembolic events, suggesting the possibility that TPO-RA alters
the platelet function. The aim of this study is to test our hypothesis that
TPO-RA increases platelet activity and alters immune profiles in ITP.
Study objective
To evaluate possible changes in immune profiles and platelet function after
start of a TPO-RA.
Study design
non-interventional, non-randomized, non-blinded, observational trial design.
Study burden and risks
At least four out of five times, the blood sample will be taken during a
scheduled venipuncture, as part of standard of care. Because only a small
volume will be withdrawn, the risk is considered negligible. Possibly, one
extra venipuncture is necessary. Venipunctures are carried out very often in
ITP patients and the associated risk is considered low. Possible risks of the
venipuncture are formation of a small, local hematoma and pain/discomfort.
Patients are asked to come the UMC Utrecht for the venipuncture: travel
expenses and parking costs will be compensated. The blood results that are
relevant for the patient*s treatment will be sent to the patient*s physician,
so the study withdrawals will be combined with the standard of care
venipuncture.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Age 16 years and older
- Previously confirmed diagnosis of primary ITP with current platelet counts of
<100x10^9/L
- Will start treatment with eltrombopag
- Willing and be able to understand the study information and sign the informed
consent form.
Exclusion criteria
- Documented history of persisting severe anemia (defined as hemoglobin <6.0
mmol/L for men and women)
- Treatment with rituximab in the past 9 months
- Treatment with any immune modulating drug other than corticosteroids in the
past 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66840.041.18 |