EUCTR2009-016950-42-GB进行中（未招募）不适用
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy.
Shionogi USA, Inc.0 个研究点目标入组 60 人开始时间: 2010年6月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •1. A signed and dated written informed consent obtained prior to the performance of Screening procedures.
- •2. Males and females = 18 years of age prior to Screening.
- •3. All subjects must agree to use exclusively progestin-based and/or barrier method contraception if engaging in sexual intercourse. Female subjects of child bearing potential must not be breast-feeding and must use a reliable barrier method for at least 7 days prior to the first dose of study drug and continuing throughout the study until 6 weeks after the last dosing, except if surgically sterilized or have been post-menopausal for at least 12 months. Hormone based contraceptives (e.g., pills, patch, shots, implants) that are not exclusively progestin-based are prohibited. Male subjects should either remain abstinent or use a condom during the time interval between taking the first dose and 6 weeks following the last study drug dose.
- •4. Diagnosis of ITP by American Society of Hematology criteria for at least 12 weeks prior to Screening.
- •5. Subjects > 60 years of age must have had a diagnostic bone marrow aspiration showing normal or increased numbers of megakaryocytes.
- •6. Relapsed persistent or chronic ITP status, with or without prior splenectomy (exception: in Hungary only splenectomized subjects will be enrolled), after having failed at least 1 prior ITP therapy (excluding TPO agonists) and have a platelet count < 30,000/µL if not taking medications or < 50,000/µL despite concomitant steroids or other ITP therapies, such as danazol or immunosuppressive drugs.
- •7. Subjects receiving chronic maintenance steroid therapy must have received a stable dose (same milligram amount ± 10%) for at least 2 weeks prior to Screening.
- •8. Prothrombin time (PT) and activated partial thromboplastin time (APTT) within 20% of the upper limit of normal at Screening.
- •9. Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed. The dosages of all these medications must be stable for at least 4 weeks prior to Visit 1 (Day 1).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for study participation if he/she meets any of the exclusion criteria, or will be discontinued at the discretion of the investigator if he/she develops one or more of the following exclusion criterion during the study:
- •1. History of inherited or acquired, clinically important hemorrhagic clotting disorder.
- •2. Females who are pregnant or lactating, or are receiving other hormone/chemical contraceptives that are not exclusively progestin-based.
- •3. History of alcohol/drug abuse or dependence within 1 year of Screening.
- •4. Use of the following drugs or treatment prior to Visit 1 (Day 1):
- •Within 1 week – Rho(D) immune globulin or intravenous immunoglobulin (IVIG);
- •Within 2 weeks – platelet transfusions or plasmapheresis treatment
- •Within 4 weeks - use of anti-platelet or anti-coagulant drugs.
- •Within 8 weeks – rituximab;
- •Within 12 weeks – alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
- •5. History of clinically significant (in the opinion of the investigator) cardiovascular or thromboembolic disease within 26 weeks prior to Screening Visit.
- •6. Splenectomy within 4 weeks prior to Screening.
- •7. Laboratory abnormalities:
- •Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP;
- •Absolute neutrophil count < 1000/mm3;
- •Abnormal peripheral blood smear;
- •Total bilirubin > 1.5 x upper limit of normal;
- •Alanine aminotransferase (ALT) > 1.5 x upper limit of normal;
- •Aspartate aminotransferase (AST) > 1.5 x upper limit of normal;
- •Creatinine > 1.5 x upper limit of normal;
- •Human immunodeficiency virus (HIV) positive;
- •Hepatitis A IgM antibody (IgM HAV) positive, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV) positive;
- •Thyroid stimulating hormone (TSH) > 1.5 x upper limit of normal;
- •Free thyroxine (T4) > 1.5 x upper limit of normal.
- •8. Exposure to previous approved TPO mimetics/agonists eltrombopag within 2 weeks or romiplostim within 4 weeks prior to dosing.
- •9. Subjects unresponsive, defined as the inability to attain adequate platelet count despite optimal dosing of previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665), based on investigator’s discretion.
- •10. Exposure to an investigative medication within 4 weeks prior to Screening.
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