ISRCTN22065123已完成不适用
A pilot study of Combivir® therapy for patients with primary biliary cirrhosis
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)0 个研究点目标入组 60 人开始时间: 2003年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients will be recruited from the Liver Out-Patients Department at the Queen Elizabeth Hospital:
- •1. Patients greater than 20 years old of either sex
- •2. Elevated alkaline phosphatase or alanine aminotransferase (ALT) within 3 months prior to the start of therapy
- •3. Positive serum anti-mitochondrial antibodies (AMA) (titre greater than 1:20)
- •4. Liver biopsy histology compatible with PBC
排除标准
- •1. Patients treated with immunosuppressive or anti-inflammatory agents
- •2. Advance liver disease: Child's class B or C
- •3. Patients with secondary hepatological diagnosis
- •4. Alcohol abuse (greater than 50 g of alcohol per day)
- •5. Other significant co-morbidity (e.g. cardiac or renal failure)
- •6. Pregnancy or breast feeding
- •7. Sexually active female of child bearing age not using effective contraception
研究者
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