EUCTR2013-003629-27-SE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
Bioverativ Therapeutic Inc.0 个研究点目标入组 60 人开始时间: 2014年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
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 Any subject who is enrolled based on results of the local laboratory must be withdrawn if the central laboratory screening results indicate a baseline FIX activity level 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: 60
- •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. History of positive inhibitor testing. A prior history of inhibitors is defined based on a patient's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (i.e., equal to or above lower limit of detection).
- •2. History of hypersensitivity reactions associated with any rFIXFc administration.
- •3. Exposure to blood components or injection with a FIX concentrate (including plasma derived) other than rFIXFc.
- •4. Injection with commercially available rFIXFc more than 28 days prior to Screening.
- •5. More than 3 injections of commercially available rFIXFc prior to confirmation of eligibility.
- •6. Other coagulation disorder(s) in addition to hemophilia B.
- •7. Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the subject unsuitable for enrollment (e.g., HIV infection with CD4 lymphocyte count <200 cells/µL or a viral load >200 particles/µL, or any other known congenital or acquired immunodeficiency).
- •8. Current systemic treatment with chemotherapy and/or other immunosuppressant drugs. Use of steroids for treatment of asthma or management of acute allergic episodes or otherwise life-threatening episodes is allowed. Treatment in these circumstances should not exceed a 14-day duration.
- •9. Participation within the past 30 days in any other clinical study involving investigational treatment.
- •10. Current enrollment in any other clinical study involving investigational treatment.
- •11. Inability to comply with study requirements.
- •12. Other unspecified reasons that, in the opinion of the Investigator or Bioverativ, make the subject unsuitable for enrollment.
研究者
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