Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- sustained virologic response (SVR)rate
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 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines
- Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
- whether Vitamin D levels predicts negative treatment outcome.
详细描述
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age
- •chronic genotype 2,3 HCV infection
- •treatment Naive negative sero for HBV, HDV and HIV viral infections
- •absolute neutrophil count of >1500 per cubic millimeter
- •a platelet count of >90,000 per cubic millimeter normal hemoglobin level
排除标准
- •decompensated liver disease (cirrhosis with CP score >9)
- •another cause of clinically significant liver disease hepato cellular carcinoma
- •psychiatric Disorder
- •chronic heart failure
- •pregnant women
- •uncontrolled diabetes with retinopathy Arrhythmia Active CAD
- •positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
研究组 & 干预措施
Peg + Vitamin D + Ribavirin
Peg + Vitamin D + Ribavirin for 3 months
干预措施: Peg + Vitamin D + Ribavirin (Drug)
Peg + Ribavirin
Peg + Ribavirin for 6 months
干预措施: Peg + Ribavirin (Drug)
结局指标
主要结局
sustained virologic response (SVR)rate
时间窗: 24 weeks
the SVR rate data will be collected and compared for 2 groups
次要结局
未报告次要终点