Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP
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|ClinicalTrials.gov Identifier: NCT05369208|
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : January 12, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Avatrombopag Oral Tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic Immune Thrombocytopenia|
|Actual Study Start Date :||June 15, 2022|
|Estimated Primary Completion Date :||November 30, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Avatrombopag 20 mg oral tablet
Drug: Avatrombopag Oral Tablet
Avatrombopag 20 mg given once daily (initial dose). Dose adjustments will be determined by the physician and in accordance with the overseas Doptelet prescribing information.
Other Name: Doptelet
- Cumulative Number of Weeks of Platelet Response [ Time Frame: 26 weeks of active treatment ]Cumulative number of weeks in which the platelet count is ≥50×10^9/L during 26 weeks of treatment in the absence of rescue therapy.
- Response Rate at Day 8 [ Time Frame: Day 8 ]Proportion of subjects with a platelet response ≥50×10^9/L at Day 8 in the absence of rescue therapy
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05369208
|Contact: Sobi Clinical||781-786-7370||NAClinical@Sobi.com|
|Responsible Party:||Sobi, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 11, 2022 Key Record Dates|
|Last Update Posted:||January 12, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders