NCT02402699已完成不适用
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load
研究概览
简要总结
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age of 18 years or older on date of first dose of Ipilimumab
- •Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan
- •Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician
排除标准
- •Patients who received Ipilimumab as part of a clinical trial
- •Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)
- •Patients who are not infected with HBV or HCV
结局指标
主要结局
Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load
时间窗: During 6months after enrollment
次要结局
未报告次要终点
研究者
研究点 (1)
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