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

Inclusion Criteria

• Subject has a confirmed diagnosis of chronic immune thrombocytopenia (ITP) (≥12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator.
• Subject has an average of 2 platelet counts 35×10^9/L). The 2 samples must be obtained ≥48 hours and ≤2 weeks apart.

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.