Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Evaluation of delayed adverse event(s) will be based on the occurrence of: New malignancy(ies); New incidence or exacerbation of a pre-existing neurologic disorder; New incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder; New incidence of a hematologic disorder; New incidence of infection related to RPx
研究概览
简要总结
To evaluate the long-term safety of patients treated with an RPx product and identify any delayed adverse event(s) related to treatment with an RPx product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient has received at least 1 dose of an RPx product and has completed or discontinued participation in the parent study.
- •Patient or patient’s legal guardian has provided signed informed consent (or assent), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Cannot comply with the requirements of the study.
结局指标
主要结局
Evaluation of delayed adverse event(s) will be based on the occurrence of: New malignancy(ies); New incidence or exacerbation of a pre-existing neurologic disorder; New incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder; New incidence of a hematologic disorder; New incidence of infection related to RPx
Evaluation of delayed adverse event(s) will be based on the occurrence of: New malignancy(ies); New incidence or exacerbation of a pre-existing neurologic disorder; New incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder; New incidence of a hematologic disorder; New incidence of infection related to RPx
New herpetic infection and presence of RPx detected in samples collected from herpetic lesions
New herpetic infection and presence of RPx detected in samples collected from herpetic lesions
次要结局
未报告次要终点
研究者
Kari Jeschke
Scientific
Replimune Group Inc.