An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)

Exclusion Criteria

• •History of clinically important hemorrhagic clotting disorder
• •Females who are pregnant, lactating, or taking oral contraceptives
• •History of alcohol/drug abuse or dependence within 1 year
• •Use of the following drugs or treatment prior to Visit 1 (Day 1):
• •* Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin;
• •* Within 2 weeks - plasmaphoresis treatment;
• •* Within 4 weeks - use of anti-platelet or anti-coagulant drugs;
• •* Within 8 weeks - rituximab;
• •* Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
• •History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Initial Screening
• •Splenectomy within 4 weeks prior to Initial Screening
• •Clinically significant laboratory abnormalities
• •* Hemoglobin \< 10.0 g/dL for men or women, not clearly related to ITP
• •* Absolute neutrophil count \< 1000/mm3
• •* Abnormal peripheral blood smear with evidence of fibrosis confirmed by bonemarrow biopsy
• •* Total bilirubin \> 1.5 x upper limit of normal
• •* Alanine aminotransferase (ALT) \> 1.5 x upper limit of normal
• •* Aspartate aminotransferase (AST) \> 1.5 x upper limit of normal
• •* Creatinine \> 1.5 x upper limit of normal
• •* Human immunodeficiency virus positive
• •* Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive
• •Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 \[AKR-501\] or LGD-4665) within 4 weeks prior to Initial Screening
• •Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 \[AKR-501\] or LGD-4665)
• •Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit