EUCTR2009-017942-30-IT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 - ND
SHIONOGI USA, INC0 个研究点目标入组 60 人开始时间: 2010年4月27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 continue to meet all inclusion criteria of the previous study, listed below, including platelet counts < 50,000/µL to be eligible for study participation. For the purpose of this protocol, initial screening visit and all pre-study time periods refer to protocol 0913M0621. 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 the Phase 2 ITP Study 0913M0621 exclusion criteria, listed below, and a subject will be discontinued at the discretion of the investigator if he/she develops one or more of the following exclusion criterion during the study. For the purpose of this protocol, initial Screening Visit and all prestudy time periods refer to protocol 0913M0621. 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
相似试验
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 splenectomyRelapsed persistent or chronic immune thrombocytopenia with or without prior splenectomyMedDRA version: 12.1Level: LLTClassification code 10066667Term: Chronic thrombocytopeniaMedDRA version: 12.1Level: LLTClassification code 10063129Term: Persisting thrombocytopeniaEUCTR2009-017942-30-DEShionogi USA, Inc.60
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 splenectomyEUCTR2009-017942-30-GBShionogi USA, Inc.60
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 splenectomyEUCTR2009-017942-30-FRShionogi USA, Inc.60
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 splenectomyRelapsed persistent or chronic immune thrombocytopenia with or without prior splenectomyMedDRA version: 12.1Level: LLTClassification code 10066667Term: Chronic thrombocytopeniaMedDRA version: 12.1Level: LLTClassification code 10063129Term: Persisting thrombocytopeniaEUCTR2009-017942-30-HUShionogi USA, Inc.60
终止
2 期
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)Immune ThrombocytopeniaNCT01129024Shionogi19