EUCTR2007-003642-15-DE进行中（未招募）不适用
A Randomized, Double-blind Superiority Trial to Evaluate the Safety, Tolerability, and Efficacy of Belimumab in Refractory ITP Subjects
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Age 18 – 70 years
- •Gender: male or female
- •Diagnosed ITP for at least 6 months prior to screening, and have a platelet count of <30.000 platelets/mikroliter on Day 1.
- •Refractory patients who have either not responded to one or more prior therapies, or have relapsed within 3 months prior therapy. Previous therapies include corticosteroids, IVIG, anti-D immunoglobulin, azathioprine, danazol, cyclophosphamide, immunomodulators and/or splenectomy. Previous therapies with immunoglobulins, immunomodulators and cyclophosphamide must have been completed at least two weeks prior to randomization.
- •Subjects with maintenance immunosuppressive therapy (corticosteroids, azathioprine, danazol, cyclosporine A, MMF) and inadequate increase of platelets (<30,000/mikroliter).
- •Subjects treated with maintenance immunosuppressive therapy (corticosteroids, danazol, cyclosporine A) must be receiving a dose that has been stable for at least 1 month.
- •Normal protrombin time (PTT) and activated partial thromboplastin time (aPTT).
- •A complete blood count, reticulocyte count, creatinine, ALT, AST, bilirubin within the reference range with the following exceptions:
- •Platelet count < 30.000/mikroliter
- •Hemoglobin: female and male >= 10.0 g/dL are eligible for inclusion.
- •ANC>=1500/mikroliter is required for inclusion; elevated WBC/ANC due to steroid treatment is acceptable.
- •Subject is practicing an acceptable method of contraception (documented in chart). Female subject or female partners of male subjects must either be on non-childbearing potential (hysterectomy, bilateral, oophrenectomy, bilateral tube ligation or post-menopausal >=1 year).
- •Complete abstinence of intercourse
- •Intrauterine device
- •Two forms of barriers contraception
- •Male partner is sterile and the one partner of the female. Contraception: if subject is male – partner is sterile, if female – subject sterile.
- •Systemic contraceptives (combined or progesterone only)
- •Subject is able to understand and comply with the protocol requirements and instructions and intends to complete the study as planned
- •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
- •History of thrombosis within the last year.
- •Pre-existing cardiac disease; myocardial infarction in the last three months
- •Female subjects who are nursing or pregnant (positive serum or urine
- •Subject has consumed aspirin, aspirin containing compounds, anti-coagulants or non-steroidal anti-inflammatories for > 3 consecutive days within 2 weeks during the study.
- •Any laboratory or clinical evidence for HIV, Hepatitis C, chronic Hepatitis B infection beta-chorionic gonatrotropin pregnancy test) at screening at pre-dose on Day 1.
- •History of alcohol/drug abuse or dependence within 12 months of the study.
- •Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- •A complete blood count (CBC) and/or reticulocyte count outside the reference range , with the following exceptions:
- •Platelet count < 30.000/mikroliter is required for inclusion.
- •Haemoglobin: females and males >=10 g/dL are eligible for inclusion.
- •ANC>=1500/mikroliter (1.5 x 109/L) is eligible for inclusion.
- •History of platelet aggregation that prevents reliable measuring of platelet counts.
- •An laboratory or clinical evidence for HIV infection; an clinical history or laboratory evidence for hepatitis C infection; an clinical history or laboratory evidence for hepatitis B infection; or any evidence for active hepatitis at the time of subject screening; if the potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however standard medical practice would suggest evaluation of patients who have risk factors for these infections.
- •Persons who are detained officially or legally to an official institute
- •Women of childbearing age without highly effective contraception (PEARL-Index < 1%)
研究者
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