EUCTR2012-005489-37-AT进行中（未招募）1 期
A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
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
- •Main study inclusion criteria:
- •For previously treated subjects, either:
- •Completed a CSL-sponsored rIX-FP (CSL654) study, including study
- •CSL654_3001 [NCT01496274] or study CSL654_3002 [NCT01662531].
- •Scheduled to have a major non-emergency surgery within
- •approximately 8 weeks from the anticipated date of receiving the first
- •rIX-FP injection.
- •Not previously completed a CSL-sponsored rIX-FP lead-in study.
- •Male, 12 to 70 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 EDs, confirmed by their treating physician.
- •No confirmed history of FIX inhibitor formation at screening by the
- •central laboratory
- •For previously untreated subjects:
- •Male, up to 18 years of age.
- •Documented severe hemophilia B (FIX activity of = 2%), or confirmed
- •at screening by the central laboratory.
- •Never previously been treated with FIX clotting factor products
- •(except previous exposure to blood components).
- •No confirmed history of FIX inhibitor formation
- •Surgery substudy inclusion criterion:
- •Must require non-emergency surgery
- •Subcutaneous substudy inclusion criteria:
- •Male, at least 18 years of age.
- •Subjects currently enrolled in Study CSL654_3003
- •Subjects who have received rIX-FP for = 100 EDs (single-dose cohorts)
- •or for = 50 EDs (repeated-dose cohort)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main study exclusion criteria:
- •Currently receiving a therapy not permitted during the study.
- •Any issue that, in the opinion of the investigator, would render the
- •subject unsuitable for participation in the study.
- •For subjects who have previously completed a CSL-sponsored rIX-FP
- •Unwilling to participate in the study for a total of 100 exposure days.
- •For subjects requiring major non-emergency surgery who have not
- •previously completed a CSL-sponsored rIX-FP lead-in study:
- •Known hypersensitivity (ie, 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.
- •Low platelet count, kidney or liver disease.
- •Human immunodeficiency virus positive with a CD4 count < 200/mm3.
- •For previously untreated subjects:
- •Known congenital or acquired coagulation disorder other than
- •congenital FIX deficiency (except for vitamin K deficiency of the
- •Known kidney or liver dysfunction or any condition which, in the
- •investigator's opinion, place the patient at unjustifiable risk.
- •The surgical sub-study does not have any additional exclusion criteria,
- •although subject(s) in France will not be eligible for the surgery substudy.
- •Subcutaneous substudy exclusion criteria:
- •Intravenous use of rIX-FP within 14 days of subcutaneous
- •administration of rIX-FP.
- •Life-threatening bleeding episode or major surgery during the 3 months
- •prior to substudy entry
研究者
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