EUCTR2010-020558-33-IT进行中（未招募）不适用
A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects with Severe Hemophilia A. - ND
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
- 180
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
- Male
入选标准
- •1. Provide written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). Parental or guardian consent is required for subjects who are less than 18 years of age. Subjects less than 18 years of age should consent to the study providing a signed assent form if required by local regulations. 2. Male, =12 years of age and weighing at least 40 kg 3. Have severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII as determined by one-stage clotting assay from the central laboratory at the time of screening. If the screening result is =1%, then the severity of hemophilia A may be confirmed by documented historical evidence from a certified clinical laboratory demonstrating <1% FVIII:C as determined by the one-stage clotting assay from the medical record or from a documented genotype known to produce severe hemophilia A. 4. Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 0 (Advate or rFVIIIFc). Fresh frozen plasma treatment must not be considered in the count for the documented exposure days.
- •Are the trial subjects under 18? yes
- •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
- •1. History of, or currently detectable inhibitor titer as defined by the central laboratory (family history of inhibitors will not exclude the subject) 2. Other coagulation disorder(s) in addition to hemophilia A 3. History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration 4. For the PK subgroup only: known hypersensitivity to mouse or hamster proteins 5. Currently taking (or likely to require during the study) acetylsalicylic acid (ASA) or ibuprofen (other non-steroidal anti-inflammatory drugs are permitted).
研究者
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