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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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).
研究者
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