NCT02624141终止4 期
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Hemoglobin Levels at 16 Weeks
研究概览
简要总结
This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients with a non-myeloid malignancy
排除标准
- •Transfusion of red blood cells within 2 months of study drug
- •Treatment-resistant hypertension
- •Acute or chronic bleeding (requiring therapy) within 3 months of study drug
研究组 & 干预措施
Epoetin Beta 30000 IU
Experimental
Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks.
干预措施: Epoetin Beta (Drug)
结局指标
主要结局
Hemoglobin Levels at 16 Weeks
时间窗: 16 Weeks
次要结局
- Serum Iron Levels(16 Weeks)
- Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument(Up to 4 months)
- Tolerability - Incidence of Adverse Events(Up to 4 months)
- Serum Transferrin Levels(16 Weeks)
- Percentage of Participants With A Positive Response(16 Weeks)
- Time To Global Response(Up to 4 months)
- Quality of Life In Relation to Anemia Grade(Up to 4 months)
- Serum Ferritin Levels(16 Weeks)
研究者
相似试验
终止
4 期
A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin BAnemiaNCT02608060Hoffmann-La Roche4
Unknown
不适用
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood ManagementSurgeryNCT01686659Society for the Advancement of Blood Management, Inc470
已完成
4 期
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.AnemiaNCT00737464Hoffmann-La Roche132
已完成
3 期
MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants With Chronic Renal AnemiaAnemiaNCT00545571Hoffmann-La Roche120
已完成
3 期
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal AnemiaAnemiaNCT00773968Hoffmann-La Roche140