EUCTR2013-003573-10-GB进行中（未招募）1 期
Can Vitamin D supplementation improve Hepatitis C cure rates: A pilot multicentre randomised controlled clinical trial - The ViaDUCT study
niversity of Dundee & NHS Tayside0 个研究点目标入组 160 人开始时间: 2013年9月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have confirmed hepatitis C with positive PCR for genotype 1 or 3
- •Are planned to commence on standard eradication therapy for HCV
- •Aged 18 or over
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Hepatitis C genotype other than 1 or 3
- •Previous treatment with interferon/ribivarin
- •Contraindications to interferon / ribavirin therapy
- •eGFR <30 ml/min (by MDRD4 method)
- •Currently decompensated liver disease
- •oAscites, encephalopathy or variceal bleeding
- •History of renal calculi
- •Serum calcium <2.15 mmol/L or >2.60 mmol/L
- •History of sarcoidosis, metastatic malignancy
- •Hepatocellular carcinoma (current or previous)
- •Taking >400 units/day of vitamin D
- •HIV positive
- •Breastfeeding
- •Of childbearing potential and not taking reliable contraception
- •Participation in another drug trial concurrently or within 30 days of screening for this one
- •Unable to provide written informed consent
研究者
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