EUCTR2011-002415-28-IT进行中（未招募）不适用
A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B
试验速览
- 阶段
- 不适用
- 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
- •Male subjects, 12 to 65 years of age. - Documented severe hemophilia B (FIX activity of = 2%), or confirmed at Screening by the central laboratory. - Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for > 150 exposure days (EDs), confirmed by their treating physician. - No confirmed prior history of FIX inhibitor formation (defined as two consecutive positive tests –requiring a confirmatory test on a second separately drawn blood sample shortly after the previous positive test), no confirmed detectable inhibitors (defined as < 0.6 Bethesda Units [BU]) at Screening by the central laboratory, and no family history of inhibitor formation against FIX. - Written informed consent for study participation obtained before undergoing any study specific procedures. For on-demand subjects ONLY: - Subjects who have experienced a minimum average of 2 non-trauma induced bleeding episodes per month in the past 3 to 6 months, which required FIX replacement therapy and are documented in their medical records. - Subjects who are willing to switch to a prophylaxis regimen.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein. - Known congenital or acquired coagulation disorder other than congenital FIX deficiency. - Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment. - Platelet count < 100,000/µL at Screening. - HIV positive subjects with a CD4 count < 200/mm3. An HIV-positive subject may participate in the study and receive antiviral therapy at the discretion of the Investigator. - Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration > 5 x ULN at Screening. - Serum creatinine concentration > 2 x ULN at Screening. - Evidence of thrombosis, including deep vein thrombosis, stroke, myocardial infarction or arterial embolus within 4 months prior to dosing on Day 1. - Experienced a life-threatening bleeding episode, including bleeding in the central nervous system, gastrointestinal tract, neck/throat or severe trauma-induced bleeding episode, or had major surgical intervention within 4 months prior to dosing on Day 1. - Use of any Investigational Medicine Product (IMP) other than rIX-FP within 4 weeks prior to the first rIX-FP administration on Day 1. - Concurrent non-hemophiliac inflammatory joint disease or other medical condition that, in the Investigator's judgment, could confound study results. - Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance. - Subjects who have active synovitis. - Subject routinely receives factor IX infusion prior to activity (ie, sports) as a preventative measure more than 2 times per month.
研究者
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