NCT00722332已完成4 期
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
Cangene Corporation16 个研究点 分布在 2 个国家目标入组 9 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 16
- 主要终点
- Efficacy of HepaGam B in combination with antiviral therapy
研究概览
简要总结
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •HBsAg-positive candidates for HBV-related liver transplant
- •Treatment with antiviral therapy before transplantation as per treating physician's recommendation. (NOTE: It is expected that most patients will receive Lamivudine or Adefovir Dipivoxil pre-transplant. In the case of antiviral resistance, an effective alternative antiviral agent(s) must be used.)
排除标准
- •Multi-organ transplantation recipients
- •Liver re-transplantation except for primary non-function
- •Presence of a hepatoma (larger than 5.0 cm as a solitary node) or 2 to 3 multi-focal nodes (larger than 3.0 cm each) (Milan Criteria) based on information available at baseline visit (CT scan, MRI).
- •Patients requiring an OLT (Orthotopic Liver Transplant)due to fulminant hepatitis B
- •OLT patients receiving a liver graft from a donor that is positive for HBsAg
- •Patients using interferon pre-transplant (as interferon cannot be used post-transplant)
- •History of IgA (immunoglobulin A) deficiency
- •History of hypersensitivity to blood products.
- •HIV or HCV positive
- •Use of an investigational product, or participation in another clinical trial during the course of the study (with the exception of quality-of-life or repository studies)
- •Pregnancy or planned pregnancy during the course of the study
结局指标
主要结局
Efficacy of HepaGam B in combination with antiviral therapy
时间窗: 15 month follow-up
次要结局
- Pharmacokinetic profile and safety of HepaGam B in combination with antiviral therapy(15 month follow-up)
研究者
研究点 (16)
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