NCT02910557已完成不适用
A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® in Clinical Practice to Characterize Risk of Herpetic Infection Among Patients, Close Contacts, Health Care Providers & Long-term Safety in Treated Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 187
- 试验地点
- 23
- 主要终点
- Incidence Rate
研究概览
简要总结
A postmarketing Cohort study of Melanoma patients treated with IMLYGIC (Talimogene Laherparepvec) in clinical Practice to Characterize the risk of herpetic infection with detection of Talimogene Laherparepvec DNA among patients, close contacts, and health care providers; and long term safety in treated patients for up to 5 years after the first IMLYGIC dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent
- •Patient is an adult (≥ 18 years of age at the time of informed consent) with a diagnosis of melanoma
- •Patient enrolled within 1 month of receiving the first dose of IMLYGIC for the treatment of melanoma
排除标准
- •- Patient has a prior history of being a subject in an interventional clinical trial for IMLYGIC
结局指标
主要结局
Incidence Rate
时间窗: Up to 5 years
Estimate the incidence rate of herpetic infection with detection of talimogene laherparepvec (T-VEC) DNA among patients for up to 5 years after the first IMLYGIC dose.
次要结局
- Use of Drug Therapies(Through study completion, average of 5 years)
- Patient Demographics(Through study completion, average of 5 years)
- Herpectic Infection with T-VEC DNA for Close Contacts and Healthcare Providers (HCPs)(Through study completion, average of 5 years)
- Incidence of Herpetic Infection with T-VEC in Patients During Treatment(Through treatment period, up to 1 year)
- Incidence of HSV-1 DNA in Patients After Treatment(Through study completion, average of 5 years)
- Incidence of Adverse Events and Serious Adverse Events in Patients(Through study completion, average of 5 years)
- Incidence of Herpetic Infection with T-VEC in Patients After Treatment(Through study completion, average of 5 years)
- Incidence of Herpes Simplex Virus 1 (HSV-1) DNA in Patients During Treatment(Through treatment period, up to 1 year)
- Overall Survival(Through study completion, average of 5 years)
研究者
研究点 (23)
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