NCT02608060终止4 期
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Using Pre-filled Syringe With 30000 IU, as Well as to Quantify the 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
- 4
- 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 subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 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 participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
- •Anemia at Screening Visit
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 if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
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
- Percentage of Participants with a Positive Response(Weeks 4 and 8)
- Quality of Life in Relation to Grade of Anemia(Up to 4 months)
- Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument(Up to 4 months)
- Tolerability - Incidence of Adverse Events(Up to 16 Weeks of treatment period)
- Serum Iron, Ferritin and Transferrin Levels(16 Weeks)
- Time to Global Response(Up to 4 months)
研究者
相似试验
终止
4 期
A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid MalignancyAnemiaNCT02624141Hoffmann-La Roche10
Unknown
不适用
Noninvasive and Continuous Hemoglobin Monitoring for Surgical Blood ManagementSurgeryNCT01686659Society for the Advancement of Blood Management, Inc470
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
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
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal AnemiaAnemiaNCT00773968Hoffmann-La Roche140