EUCTR2011-000830-12-BE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women = 18 years of age
- •2. Subjects diagnosed with cITP (=12 months duration) according to the ASH/BCSH guidelines, with 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 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 and activated partial
- •thromboplastin time 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 white
- •blood count [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 is clearly attributable to ITP (excessive blood loss).
- •Absolute neutrophil count (ANC) = 1500/µL (1.5 x 109/L)was required for inclusion (elevated WBC/ANC due to corticosteroid treatment is acceptable).
- •Elevated WBC or ANC (e.g., due to corticosteroid treatment) provided this is discussed with the medical monitor (revised per Amendment 01)
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. 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)(Revised per Amendment 01)
- •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 on 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 gastric atrophy (added per Amendment 01)
- •6. History of pernicious anemia or subjects with vitamin B12 deficiency (defined as 7. 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:
- •hormone replacement therapy, 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.
- •8. 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 corrected for heart rate of > 450 msec, angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting)
- •9. Subjects with a history of cirrhosis, portal hypertension, and chronic
- •active hepatitis
- •10. Subjects with concurrent malignant disease
- •11. Use of immunoglobulins (IVIg and anti-D) within 1 week of
- •randomization
- •12. Splenectomy or use of rituximab within 12 weeks of randomization
- •13. Use of romiplostim or eltrombopag within 4 weeks of randomization
- •14. 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
- •15. 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
- •16. Use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of randomization.
- •17. Subjects who are currently treated with proton pump inhibitors (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
- •18. Fasting gastrin-17 blood levels exceeding the upper limit of normal (ULN) at Screening for subjects not on PPIs or H2 antagonists (revised per Amendment 01)
- •19. Fasting gastrin-17 blood levels exceeding 1.5 times the ULN at Screening for subjects on PPIs or H2 antagonists (added per Amendment 01)
- •20. Blood creatinine exceeding ULN by more than 20% OR total albumin below the lower limit (LLN) of normal by 10% (revised per Amendment
研究者
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