Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Gather data
研究概览
简要总结
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.
详细描述
Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.
The company is also collecting data related to whether a patient received a liver transplant and on survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects participating in the VTI-206 clinical trial.
排除标准
- •Subjects not participating in the VTI-206 clinical trial.
研究组 & 干预措施
AOCH patients
Patients with acute on chronic hepatitis
干预措施: ELAD (Extracorporeal Liver Assist System) (Drug)
AAH patients
Patients with acute alcoholic hepatitis
干预措施: ELAD (Extracorporeal Liver Assist System) (Drug)
结局指标
主要结局
Gather data
时间窗: Five years post study participation
See previous description
次要结局
未报告次要终点