Thrombocytopenia
Conditions
Keywords
Platelet refractory thrombocytopenia
Brief summary
This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.
Interventions
DRUGEltrombopag
75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day
Sponsors
GlaxoSmithKline
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Laboratory diagnosis of platelet refractoriness * Diagnosis of platelet dependence * Adequate liver and renal laboratory screening tests
Exclusion criteria
* Patients with thrombocytopenia that are responsive to platelet therapy * Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day | 3 years average |
Countries
United States
Outcome results
None listed