Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia

Exclusion Criteria

• •Have diagnosis of Fanconi anemia
• •Have infection not adequately responding to appropriate therapy
• •Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater than or equal to 50%
• •Have known HIV positivity
• •Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal
• •Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper limit of normal if the patient has been treated with ATG within three weeks of screening.
• •Have AST and/or ALT ≥ 3 times the upper limit of normal
• •Have hypersensitivity to eltrombopag or its components
• •Have chemotherapy given less than or equal to 14 days prior to initiating the study medication. This does not include immunosuppressive agents and growth factor as described above
• •Are female and are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
• •Are unable to understand the investigational nature of the study or give informed consent
• •Have a history of arterial or venous thrombosis within the last 1 year (excluding those due to indwelling lines)
• •Have an ECOG performance status of 3 or greater
• •Have had treatment with Campath within 6 months of entry into the study
• •Have pre-existing cardiovascular disease (congestive heart failure with New York Heart Association \[NYHA\] grade III/IV), arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), unstable angina, or QTc \> 450 msec (QTc 480 msec for subjects with bundle branch block), or myocardial infarction within the preceding 6 months) at study entry
• •Have had other TPO-R agonists medication in the previous 4 weeks.