EUCTR2011-002415-28-ES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/?L 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
- •- Use of any Investigational Medicine Product (IMP) other than rIX-FP within 4 weeks prior to the first rIX-FP administration on
- •- 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
研究者
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