NL-OMON56981
尚未招募
不适用
An exploratory study to evaluate in vivo, ex vivo and clinical hypersensitivity reactions after first-time treatment with complement-reactogenic infusions - In vivo and ex vivo complement activation
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Centre for Human Drug Research
- 入组人数
- 60
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patients who have an indication for receiving potentially complement
- •reactogenic treatments (e.g. paclitaxel or liposomal doxorubicin (Caelyx))
- •according to their clinical treatment protocol as prescribed by their treating
- •medical specialist. Patients eligible for participation may include, but will
- •not be limited to, patients with breast cancer or ovarian cancer.
- •2\. Able and willing to give written informed consent and to comply with the
- •study restrictions.
- •3\. Has the ability to communicate well with the Investigator in the Dutch or
- •English language and willing to comply with the study restrictions.
排除标准
- •1\. Previous treatment with same complement reactogenic treatment (e.g.
- •paclitaxel or liposomal doxorubicin (Caelyx) (e.g. in case of reintroduction)
- •2\. Subjects with poor venous access limiting phlebotomy.
- •3\. Patients with known complement deficiencies.
- •4\. Patients who received plasma infusions within a week of the first infusion
- •5\. Any condition that would, in the opinion of the investigator, potentially
- •compromise the safety of the patient or may preclude the patient\*s successful
- •completion of the clinical trial.
- •6\. Patients receiving chemotherapeutic combination therapy during the study
- •period (first treatment day).
结局指标
主要结局
未指定
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