EUCTR2013-003629-27-ES进行中（未招募）1 期
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- Male
入选标准
- •1. Ability of the subject or their parent or legal guardian to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) or equivalent, and/or to provide assent in accordance with national and local regulations.
- •2. Male, age <18 years at the time of informed consent.
- •3. Weight ?3.5 kg at the time of informed consent.
- •4. Severe hemophilia B defined as ?2 IU/dL (?2%) endogenous FIX documented in the medical record or as tested during the Screening Period. Any subject who is enrolled based on results of the local laboratory must be withdrawn if the central laboratory screening results indicate a baseline FIX activity level >2% of normal.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Prior history of inhibitor as defined by the reporting laboratory (family history of inhibitors will not exclude the subject). The historical positive inhibitor test is defined as per local laboratory Bethesda value for a positive inhibitor test (i.e., equal to or above lower level of detection).
- •2. Measurable inhibitor activity (as defined in Section 10.2.4) at the Screening Visit, measured using the Nijmegen-modified Bethesda assay performed at the central laboratory. A negative inhibitor test result at the local laboratory may be used initially to determine subject eligibility, however any subject who is enrolled based on results of the local laboratory must be withdrawn if the central laboratory screening results indicate a positive inhibitor.
- •3. History of hypersensitivity reactions associated with any IV immunoglobulin administration.
- •4. History of hypersensitivity reactions associated with any rFIXFc administration.
- •5. Injection with a FIX concentrate other than rFIXFc.
- •6. Injection with rFIXFc more than 28 days prior to Screening.
- •7. More than 3 injections of rFIXFc prior to confirmation of eligibility.
- •8. Other coagulation disorder(s) in addition to hemophilia B.
- •9. Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
- •10. Current systemic treatment with chemotherapy and/or other immunosuppressant drugs, with the following exceptions: use of steroids for treatment of asthma or management of acute allergic episodes.
- •11. Participation within the past 30 days in any other clinical study involving investigational treatment.
- •12. Current enrollment in any other clinical study involving investigational treatment.
- •13. Inability to comply with study requirements.
- •14. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
研究者
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