Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP (NCT05369208) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP
Japan19 participantsStarted 2022-06-15
Plain-language summary
Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).
Who can participate
Age range18 Years
SexALL
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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 \<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., 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 an…