acquired severe aplastic anemia
Conditions
Interventions
Treatment with eltrombopag and cyclosporine.
aplastic
cyclosporine
eltrombopag
anemia
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Male and female >= 18 years of age. • Severe aplastic anemia characterized by a. Bone marrow cellularity
Exclusion criteria
Exclusion criteria: • Fanconi anemia. • Evidence of a clonal hematologic bone marrow disorder. See protocol page 40 for details. • Prior immunosuppressive therapy with cyclosporine, alemtuzumab, r- or h-ATG and TPO-R agonists. • Liver cirrhosis. • Infection not adequately controlled with appropriate therapy. • Moribund or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, cancer or metabolic disease of such severity that it would interfere with a proper completion of study visits or treatment. • Pregnant or nursing (lactating) women. • Females and males not using adequate contraception. See protocol page 45 for more details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and 12 months, duration of hematologic response, disease relapse rate, clonal evolution, number of transfusions, time without transfusions, overall survival, symptoms and result of quality of life questionnaires, adverse events, pharmacokinetic parameters. | — |
Countries
Thailand
Outcome results
None listed