NL-OMON37816撤回3 期
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - E5501 ITP-305
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Eisai
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Men and women >= 18 years of age
- •2. Subjects diagnosed with cITP (>=12 months duration) according to the American Society for Hematology/British Committee for Standards in Hematology (ASH/BCSH) guidelines, and an average of two platelet counts < 30 × 109/L (no single count may be >35 × 109/L). In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia (e.g., pseudothrombocytopenia, myelofibrosis). The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP.
- •3. Subjects who previously received one or more ITP therapies (including, but not limited to, corticosteroids, immunoglobulins, azathioprine, danazol, cyclophosphamide and/or rituximab)
- •4. Subjects must have had either initially responded (platelet count >50 × 109/L) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndrome (MDS) or other causes of thrombocytopenia.
- •5. Prothrombin time/International Normalized Ratio (PT/INR) and activated partial thromboplastin time (aPTT) must have been within 80% to 120% of the normal range with no history of hypercoagulable state.
- •6. A complete blood count within the reference range (including WBC differential not indicative of a disorder other than ITP), with the following exceptions:
- •Hemoglobin: Subjects with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal (LLN) are eligible for inclusion, if anemia was clearly attributable to ITP (excessive blood loss).
- •Absolute neutrophil count (ANC) >= 1500/µL (1.5 x 109/L) (elevated WBC/ANC due to corticosteroid treatment is
- •acceptable).;Extension Phase
- •1. Subjects who have completed 6 months of study treatment in the Randomization Phase or
- •2. Subjects who discontinue the Core Study early due to lack of treatment effects (see Study Drug Discontinuation)
- •3. No significant safety or tolerability concerns with the subject*s participation of Randomization Phase as determined by the investigator
排除标准
- •1. Subjects with known secondary immune thrombocytopenia (e.g., subjects with known Helicobacter pylori-induced ITP, infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or with known
- •systemic lupus erythematosus [SLE])
- •2. Subjects considered unable, or unwilling to comply with the study protocol requirements or give informed consent, as determined by the investigator
- •3. Subjects with significant medical conditions that may impact the safety of the subject or interpretation of the study results (e.g., acute hepatitis, active chronic hepatitis; lymphoproliferative disease; myeloproliferative disorders, leukemia)
- •4. History of MDS
- •5. History of pernicious anemia or subjects with vitamin B12 deficiency who have not had pernicious anemia excluded as a cause
- •6. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), and more than two of the following risk factors: estrogen-containing hormone replacement or contraceptive therapies, smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden antithrombin III deficiency, etc.), or any other family history of arterial or venous thrombosis
- •7. 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], subjects with a QT interval corrected for heart rate of > 450 msec, angina, unstable angina, coronary artery stent
- •placement, angioplasty, or coronary artery bypass grafting)
- •8. Subjects with a history of cirrhosis, portal hypertension, and chronic active hepatitis
- •9. Subjects with concurrent malignant disease
- •10. Use of immunoglobulins (IVIg and anti-D) within 1 week of randomization
- •11. Splenectomy or use of rituximab within 12 weeks of randomization
- •12. Use of romiplostim or eltrombopag within 4 weeks of randomization
- •13. Subjects who are currently treated with corticosteroids or azathioprine but have not been receiving a stable dose for at least 4 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization
- •14. Subjects who are currently treated with MMF, CsA, or danazol but have not been receiving a stable dose for at least 12 weeks prior to randomization or have not completed these therapies more than 4 weeks prior to randomization
- •15. Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of randomization.
- •16. Subjects who are currently treated with PPIs or H2 antagonist therapy but have not been receiving a stable dose for at least 6 weeks prior to randomization or have not completed these therapies more than 2 weeks prior to randomization
- •17. Fasting gastrin-17 blood levels exceeding ULN (including subjects on PPIs and H2 antagonists) at Screening
- •18. Blood creatinine exceeding ULN by more than 20% OR total albumin below the LLN by 10%
- •19. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels exceeding 2 times the ULN; total bilirubin exceeding 1.5 times the ULN
- •20. Subjects with a history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy. Subjects with a history of ITP treatment with cytotoxic chemotherapy are still eligib
研究者
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