Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
研究概览
简要总结
Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy
详细描述
An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status
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
- •Chronic Hepatitis C Genotype 1 or 4
- •Hypovitaminosis D defined by a value <30 ng / ml
- •Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load <2 log at week 12 of the first course (Peg/RBV)
- •Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations
- •Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy
排除标准
- •Decompensated liver disease: Child-Pugh B> 8 or one of the following criteria: bilirubin> 35 micromol/L, TP <50%, ascites, recurrent encephalopathy
- •Positive serology for HBV and HIV
- •Alcohol consumption exceeding 50 g/day
- •Chronic intake of vitamin D
- •Thrombocytopenia <50 000/mm ³, neutropenia <750/mm ³, hemoglobin <11 g/dL
- •Pregnant women
研究组 & 干预措施
Addition of Vitamin D to Peg-interferon plus Ribavirin
干预措施: vitamin D (Drug)
结局指标
主要结局
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
时间窗: at week 12
次要结局
- Changes in HCV viral load after correction of vitamin D deficiency (delta log)(at day 0)
- Changes in HCV viral load (delta log)(at week 12)
- Negativity of HCV RNA below 12 UI/ml(at week 72)
- Changes in HCV viral load (delta log)(at week 4)
- Negativity of HCV RNA below 12 UI/ml(at week 24)