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

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sobi, Inc.

Criteria

Inclusion Criteria:

Subject has a confirmed diagnosis of chronic 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 <30×10^9/L (no single count can be >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., 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 positive [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.