Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Exclusion Criteria

• •Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or subjects with known systemic lupus erythematosus).
• •Subjects with known inherited thrombocytopenia (e.g., Myosin Heavy Chain 9 (MYH-9) disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
• •History of myelodysplastic syndrome (MDS).
• •History of arterial or venous thrombosis.
• •Subjects with a history of significant cardiovascular disease (e.g., congestive heart failure (CHF) New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events \[e.g., atrial fibrillation\], angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting).
• •Subjects with a history of cirrhosis, portal hypertension, or chronic active hepatitis.
• •Subjects with concurrent malignant disease or receiving cytotoxic chemotherapy for a reason other than ITP treatment.
• •Use of immunoglobulins (IVIg and anti-D) or corticosteroid rescue therapy within 1 week of Day 1/Baseline.
• •Splenectomy or use of rituximab within 12 weeks of Day 1/Baseline.
• •Use of romiplostim or eltrombopag within 1 week of Day 1/Baseline.
• •Use of chronic corticosteroid treatment or azathioprine within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 4 weeks.
• •Use of mycophenolate mofetil, cyclosporin A, or danazol within 4 weeks of Day 1/Baseline, unless receiving a stable dose for at least 12 weeks.
• •Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of Baseline Visit.
• •Currently receiving moderate or strong dual inhibitors/inducers of CYP2C9 and CYP3A4.
• •Serum creatinine ≥1.5× the upper limit of normal (ULN).
• •Serum bilirubin ≥2×ULN.
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×ULN.
• •Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG) test) or breastfeeding.
• •Received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) before Day 1/Baseline.