A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 13
- 主要终点
- Number of participants with Sustained virologic response (SVR)
研究概览
简要总结
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.
详细描述
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.
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
盲法说明
Vitamin D add
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 1-3 HCV infection
- •Treatment Naive
排除标准
- •Child B and C
- •HCC patients
- •Pregnancy
研究组 & 干预措施
Vit D+Peginterferon alfa 2a+Ribavirin
VitD+Peginterferon alfa 2a+Ribavirin
干预措施: Vit D (Drug)
结局指标
主要结局
Number of participants with Sustained virologic response (SVR)
时间窗: 24w after completing Peg/RBV
Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.
次要结局
- Number of participants with Rapid virological response (RVR)(Week 4)
- Number of participants with End of treatment response (ETR)(48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3)
- Number of participants with Early virological response (EVR)(Week 12)