A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
研究概览
简要总结
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
详细描述
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
- •Age of 18 years or older at time of consent
- •Bleeding indicating treatment with rThrombin during the course of the surgical procedure
- •Signed informed consent document approved by an institutional review board or independent ethics committee
排除标准
- •Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
- •Known hypersensitivity to rThrombin product or any of its components
- •Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
- •Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
- •Treatment with any experimental agent within 30 days of study enrollment or treatment
结局指标
主要结局
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
时间窗: At baseline and Day 29
Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.
次要结局
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation(Baseline through Day 29, continuously)
- Number of Participants With AEs by Maximum Severity(Baseline to Day 29, continuously)