NCT05088733Unknown早期 1 期
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia
Beijing Ditan Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the criteria of hepatocellular carcinoma
- •Patients who tested positive for hepatitis B surface antigen (HBsAg) for >6 months
- •Meet the criteria of anemia
- •Ages Eligible for Study: ≤75 years old;
- •Informed consent from the patient.
排除标准
- •Patients with upper gastrointestinal bleeding within 3 months before enrollment;
- •History of blood transfusion within 3 months before enrollment;
- •Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;
- •Serious problem of heart, lung, or kidney with severe dysfunction;
- •Pregnant or child breast feeding women;
- •Mental or cognitive disorders;
- •Participating in other drug trials;
- •Who are allergic to the study drug.
研究组 & 干预措施
Yang Yin Fu Zheng Jie Du therapy
Experimental
干预措施: Yang Yin Fu Zheng Jie Du therapy (Drug)
Yang Yin Fu Zheng Jie Du therapy
Experimental
干预措施: Routine medical care (Other)
Routine medical care
Placebo Comparator
干预措施: Routine medical care (Other)
结局指标
主要结局
Survival rate
时间窗: 1 year
次要结局
- quality of life (QOL) questionnaire(1 year)
- Objective response rate(1 year)
研究者
Zhiyun Yang
Archiater, Professor
Beijing Ditan Hospital
研究点 (1)
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