EUCTR2022-002333-34-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Chinese 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）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Male Chinese subjects aged = 70 years
- •Subjects with documented severe or moderately severe hemophilia B (FIX activity of = 2%)
- •Subjects have received FIX products for = 150 exposure days (EDs) (subjects aged = 6 years) or = 50 EDs (subjects aged < 6 years)
- •Subjects have no confirmed prior history of FIX inhibitor formation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 intravenous (IV) immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
- •Currently receiving a long-acting recombinant FIX treatment such as coagulation factor IX (recombinant), Fc fusion protein (Alprolix®).
- •Use of traditional or herbal Chinese medicine(s) with an impact on hemophilia, including coagulation, within 28 days before Day 1 and / or refusal to abstain from these during the study until the end of the subject’s participation in the study.
研究者
相似试验
进行中（未招募）
3 期
An Extension Study of TAK-664 for Japanese People with Primary Immunodeficiency DiseasePrimary Immunodeficiency DiseaseJPRN-jRCT2041210006ishizawa Atsushi12
进行中（未招募）
1 期
A study to investigate the long term safety and effectiveness of ZS (the study drug which is taken orally and acts by absorbing otassium) in patients with Hyperkalemia (excess potassium).MedDRA version: 18.1 Level: LLT Classification code 10020647 Term: Hyperkalemia System Organ Class: 100000004861HyperkalemiaEUCTR2014-004555-31-GBZS Pharma Inc751
进行中（未招募）
1 期
A study to investigate the long term safety and effectiveness of ZS (the study drug which is taken orally and acts by absorbing otassium) in patients with Hyperkalemia (excess potassium).MedDRA version: 18.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 100000004861HyperkalemiaEUCTR2014-004555-31-NLZS Pharma Inc750
进行中（未招募）
1 期
A study to investigate the long term safety and effectiveness of ZS (the study drug which is taken orally and acts by absorbing potassium) in patients with Hyperkalemia (excess potassium).HyperkalemiaEUCTR2014-004555-31-DEZS Pharma Inc750
已完成
3 期
A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemiahyperkalemiahigh potassium levels in blood10014412NL-OMON43860ZS Pharma Inc.10