Immune thrombocytopenia
Conditions
Brief summary
Platelets count at visit M3, M7, M12 and M18,, Number of patients in remission without the need for therapy at visit M7, M12, M18
Detailed description
The number of relapses within 12 months of the end of therapy, The number of patients who complete the entire cycle, The results of the standardized SF-36 quality of life questionnaire before starting, during and after treatment, Biomarker levels (kynurenine, neopterin, tryptophan) and their changes in connection with treatment, values of CD4+/CD8+ T lymphocytes and their cytokine production (IL-4, IL-17A, IFNγ), regulatory CD4+ T lymphocytes and anti-platelet antibodies as possible predictive parameters of response to therapy
Interventions
DRUGCICLOSPORIN
DRUGRITUXIMAB
DRUGDoptelet 20 mg film-coated tablets
DRUGMYCOPHENOLATE MOFETIL
Sponsors
Fakultni Nemocnice Hradec Kralove
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelets count at visit M3, M7, M12 and M18,, Number of patients in remission without the need for therapy at visit M7, M12, M18 | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of relapses within 12 months of the end of therapy, The number of patients who complete the entire cycle, The results of the standardized SF-36 quality of life questionnaire before starting, during and after treatment, Biomarker levels (kynurenine, neopterin, tryptophan) and their changes in connection with treatment, values of CD4+/CD8+ T lymphocytes and their cytokine production (IL-4, IL-17A, IFNγ), regulatory CD4+ T lymphocytes and anti-platelet antibodies as possible predictive parameters of response to therapy | — |
Countries
Czechia
Outcome results
None listed