NCT00560274已完成4 期
An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190
- 主要终点
- Blood pressure, pulse rate.
研究概览
简要总结
This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 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, >=18 years of age;
- •chronic hepatitis C;
- •quantifiable serum HCV RNA;
- •Pegylated interferon + ribavirin treatment started <6 months before study;
- •Hb <10g/dL.
排除标准
- •treatment with ESA during preceding 12 weeks;
- •poorly controlled hypertension;
- •history of cancer, except for basal cell cancer and cervical cancer in situ.
研究组 & 干预措施
1
Experimental
干预措施: Pegasys (Drug)
1
Experimental
干预措施: Ribavirin (Drug)
1
Experimental
干预措施: epoetin beta [NeoRecormon] (Drug)
结局指标
主要结局
Blood pressure, pulse rate.
时间窗: 6 and 12 months
AEs, and laboratory parameters.
时间窗: Throughout study
次要结局
- Percentage of patients achieving correction of anemia(3 months)
- Percentage of patients not requiring blood transfusion(12 months)
- Course of Hb concentration(12 months)
- Percentage of patients maintaining initial ribavirin dose(12 months)
研究者
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