NCT01413360已完成4 期
Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
研究概览
简要总结
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
详细描述
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C patients
- •positive anti-HCV antibody more than 6 months
- •serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
- •not indicated for antiviral therapy with interferon and ribavirin
- •Chronic alcoholic hepatitis
- •significant alcohol drinking history and no other cause of chronic hepatitis
- •serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
排除标准
- •Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
- •decompensated liver cirrhosis
- •platelet < 50,000/uL or white blood cell < 1,500/uL
- •need and willing for antiviral therapy
- •significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone
- •hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
- •pregnancy, lactating woman
研究组 & 干预措施
HD Vitamin C
Experimental
High dose vitamin C
干预措施: High dose vitamin C (Drug)
结局指标
主要结局
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
时间窗: Baseline and 12 weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
次要结局
- The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks(Baseline and 12 weeks)
研究者
Jung-Hwan Yoon
Professor
Seoul National University Hospital
研究点 (1)
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