NCT06313268已完成不适用
Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
Laboratorios Liomont5 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2022年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Adverse events
研究概览
简要总结
This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.
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
- •Male and female patients, 18 years and older.
- •Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).
- •Provide written informed consent.
排除标准
- •History of recent surgery or wound healing complications.
- •History of gastrointestinal perforations or fistula.
- •History of renal injury and proteinuria.
- •Recent surgical intervention.
- •Pregnant or nursing women.
- •History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.
- •Other safety concerns or bevacizumab contraindications.
研究组 & 干预措施
Test group
Bevacizumab (Effivia®)
干预措施: Bevacizumab Biosimilar MB02 (Drug)
结局指标
主要结局
Adverse events
时间窗: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)
Frequency and characteristics of adverse events (serious and non serious)
次要结局
未报告次要终点
研究者
研究点 (5)
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