Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,661
- 主要终点
- Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
研究概览
简要总结
This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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;
- •serological evidence of chronic hepatitis C;
- •detectable serum HCV-RNA;
- •liver biopsy findings consistent with a diagnosis of chronic hepatitis C.
排除标准
- •history or other evidence of a medical condition associated with chronic liver disease other than HCV;
- •co-infection with active hepatitis A or B;
- •hepatocellular carcinoma;
- •patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
研究组 & 干预措施
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
1
干预措施: ribavirin (Drug)
结局指标
主要结局
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
时间窗: From signing of informed consent up to end of study (up to Week 72)
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.
次要结局
- Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy(24 weeks after end of therapy (Week 72))
- Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation(Weeks 12,24 and 48 After Therapy Initiation)
- Percentage of Participants With Change in Hemoglobin Level(Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72))