A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,469
- 主要终点
- Percentage of Participants With Sustained Virological Response (SVR)
研究概览
简要总结
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. 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
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients >=18 years of age;
- •CHC infection (genotype 2 or 3);
- •liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- •use of 2 forms of contraception during study and 6 months after the study in both men and women.
排除标准
- •women who are pregnant or breastfeeding;
- •male partners of women who are pregnant;
- •conditions associated with decompensated liver disease;
- •other forms of liver disease, including liver cancer;
- •human immunodeficiency virus infection;
- •previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.
研究组 & 干预措施
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
1
干预措施: Copegus (Drug)
2
干预措施: Copegus (Drug)
2
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virological Response (SVR)
时间窗: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
次要结局
- Percentage of Participants With Virological Response at The End of Study Treatment(Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group))
- Percentage of Participants Virological Response 12 Weeks Post-Treatment(Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group))
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Week 40 and Week 48)
- Percentage of Participants With Marked Laboratory Abnormalities(Up to Week 40 and Week 48)
- Participants With Marked Abnormal Vital Signs(Up to Week 40 and Week 48)
- Number of Participants With Highest Triglyceride Level(Up to Week 40 and Week 48)