EUCTR2012-005489-37-BG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
- 97
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
- •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
- •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 >100EDs (single dose cohorts) or for >50 EDs (repeated-dose cohort)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 49
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 study:
- •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 newborn).
- •- 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 sub-study.
- •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
相似试验
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ESCSL Behring GmbH97
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ATCSL Behring GmbH99
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-CZCSL Behring GmbH115
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-DECSL Behring GmbH96
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ITCSL Behring GmbH85