EUCTR2012-000796-16-DE进行中（未招募）不适用
PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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 of >=18 years and <=65 years
- •Confirmed diagnosis of chronic primary ITP of at least 12 months duration and fulfilling the following criteria...
- •Platelet count of <30x10^9/L with or without bleeding manifestations.
- •Freely given written informed consent from patient.
- •Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Thrombocytopenia secondary to other diseases or drug-related thrombocytopenia.
- •Administration of intravenous immunoglobulin (IVIG), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment, except for:
- •a) long-term corticosteroid therapy
- •b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy
- •Unresponsive to previous treatment with IVIG or anti-D immunoglobulin.
- •Experimental treatment (e.g. Rituximab) within 3 months before enrolment.
- •Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
- •Patient with Evans syndrome
- •Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
- •Live viral vaccination within the last 2 months before study entry.
- •Emergency operation.
- •Severe liver or kidney disease
- •Congestive heart failure New York Heart Association (NYHA) class III or IV.
- •Non-controlled arterial hypertension
- •History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
- •Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
- •History of, or suspected alcohol or drug abuse.
- •Pregnant or nursing women.
- •Unable to consent, or not capable to understand the nature, significance and implications of the clinical study, or unable or unwilling to comply with the study procedures.
- •Vulnerable patients (e.g. kept in detention or institutionalised).
- •Participating in another interventional clinical study or planned participation in another trial for the duration of this study.
- •Receiving any investigational medicinal product (IMP) within 3 months before study entry.
- •Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of Octagam treatment.
研究者
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