Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.
详细描述
Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.
Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR
- •Pegylated Interferon-Alfa treatment naïve
- •Liver biopsy with Metavir F2 or less
- •Cognitive capacity to understand and sign the informed consent
排除标准
- •HBV or HIV co-infection
- •Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3
- •Creatinin ≥ 1.5 mg/dL
- •Severe cardiopathy
- •Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding
- •Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions
研究组 & 干预措施
Vitamins
Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
干预措施: Vitamin D (Drug)
Vitamins
Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
干预措施: Vitamin B 12 (Drug)
结局指标
主要结局
SVR12
时间窗: 12 weeks after treatment completion
Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation.
次要结局
- RVR, EVR, EOT(week 4, week 12 and at the end-of-treatment.)
研究者
Henrique Pott Junior
Dr. Henrique Pott-Junior
Federal University of São Paulo