NL-OMON47946招募中不适用
The effect of recombinant Factor IX-FIAV in In-vitro thrombin generation in hemophilia A patient samples - FIVITAS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Age 18 years or older hemophilia A patients
- •- Male sex
- •- Mentally capable of informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Prophylactic treatment with FVIII, with less than 48 hours washout period
- •between dosages of FVIII
- •- Patients receiving bypassing therapy such as prothrombin complex (FEIBA),
- •eptacog alfa (NovoSeven) or emicuzimab (HemLibra)
- •- Any other known hemostatic disorder, inherited or acquired (such as acquired
- •von Willebrand disease etc*)
- •- Any known liver disease, leading to acute or chronic liver disfunction and/or
研究者
相似试验
招募中
不适用
The effect of recombinant factor IX-FIAV in in vitro thrombin generation in hemophilia Apatient samples; FIVITASGene TherapyThrombin GenerationHemophilia ANL-OMON25584Erasmus University Medical Center Rotterdam21
进行中（未招募）
1 期
Study of a new medicinal factor IX product, IB1001, to treat patients with hemophilia BEUCTR2010-024190-39-GBAptevo Europe Limited22
已完成
3 期
A clinical trial to study the effects of IB1001,in previously treated patients children with Hemophilia BCTRI/2011/06/001832Aptevo Bio Therapeutics LLC22
进行中（未招募）
不适用
IMMUNINE - A Clinical Study with IMMUNINE (A Purified Factor IXConcentrate Virus-Inactivated) in Previously Treated Patients withSevere or Moderately Severe Hemophilia B Who are Planned to Enter theBAX 326 Study (250901, Investigating a new Factor IX Product)to expose up to 50 patients aged 12-64 years, and approximately 20 patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 20 to 50 exposure days (EDs) prospectively document the exposure days (EDs) and development of factor IX (FIX) inhibitionors if any, while receiving prophylactic treatment so that these patients can transition into the BAX 326 pivotal or pediatric study evaluating a new rFIX.MedDRA version: 14.0Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2009-016719-39-PLBaxter Innovations GmbH70
进行中（未招募）
不适用
IMMUNINE - A Clinical Study with IMMUNINE (A Purified Factor IX Concentrate Virus-Inactivated) in Previously Treated Patients with Severe or Moderately Severe Hemophilia B Who are Planned to Enter the BAX 326 Study (250901, Investigating a new Factor IX Product)EUCTR2009-016719-39-CZBaxter Innovations GmbH70