No registrations found.
ID
Source
Brief title
Health condition
Immune thrombocytopenia (ITP)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in immunologic profile and platelet function before start and during treatment with eltrombopag
Secondary outcome
Difference in immunologic profile or platelet function at baseline between responding and non-responding patients
Background summary
It has been suggested that prolonged use of TPO-receptor agonists (TPO-RA) can result in immune tolerance induction in patients with immune thrombocytopenia (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
Eltrombopag increases platelet activity and alters immune profiles in ITP
Study design
Before start of eltrombopag, and at 2-3 weeks, 3, 6 and 12 months
Inclusion criteria
- Age 16 years and older
- Previously confirmed diagnosis of primary ITP with current platelet counts of <100x109/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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8614 |
| Other | METC UMCU : METC 18-859 |