EUCTR2009-017942-30-FR进行中（未招募）不适用
An open-label safety study of S-888711 in 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3月22日最近更新:
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
- •Subjects who previously participated in the Phase 2 ITP Study 0913M0621 and who either completed treatment or discontinued treatment due to a platelet count > 400, 000/µL and must also meet all inclusion criteria listed below, including platelet counts < 50,000/µL to be eligible for study participation:
- •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, exclusively progestin-based and/or 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 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 within 1 year prior to Screening showing normal or increased numbers of megakaryocytes.
- •6. Relapsed persistent or chronic ITP status, with or without prior splenectomy, after having failed at least 1 prior ITP therapy (excluding TPO) 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 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 initial Screening Visit.
- •4. Use of the following drugs or treatment prior to Day 1:
- •Within 1 week – Rho(D) immune globulin or intravenous immunoglobulin (IVIG);
- •Within 2 weeks - plasmaphoresis 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 initial Screening Visit.
- •6. Splenectomy within 4 weeks prior to Initial Screening Visit.
- •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 with evidence of fibrosis confirmed by bone
- •marrow biopsy;
- •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 positive;
- •Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive
- •8. Exposure to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to initial Screening Visit.
- •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, other than S-888711, within the past 4 weeks prior to the initial Screening Visit.
研究者
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