EUCTR2005-001454-24-LT进行中（未招募）不适用
An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With:- Chronic viral hepatitis- Chronic alcoholic liver diseases without cirrhosis- Compensated alcoholic liver cirrhosis- Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •1. Signed Informed Consent
- •2. Female and male
- •3. Age 18 or over
- •4. Performance status: WHO 0-2
- •5. Confirmed diagnosis of one of the following:
- •Chronic viral hepatitis
- •Chronic alcoholic liver diseases without cirrhosis
- •Compensated alcoholic liver cirrhosis
- •Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis
- •6. Life expectancy of at least three months
- •7. No prior chemotherapy or radiotherapy
- •8. Haematology (WBCs = 2.0x10^9/l and platelets = 50.0x10^9/l)
- •9. Geographical and other conditions allow adequate treatment and follow up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known intolerability to cis-4-hydroxy-L-proline (CHP)
- •2. Inability or unwillingness to give written informed consent
- •3. Inability or unwillingness to co-operate adequately
- •4. Inability to take medication orally
- •5. Acute intercurrent illness
- •6. Uncontrolled concomitant diseases (diabetes, hypertension, cardiac disorders, etc)
- •7. Pregnant or lactating women
- •8. Concomitant medication or procedures which could interfere with the study or with basic therapy or with the study medication
- •9. Current participation in another clinical study or participation in any other study during the 30 days before the start of this study
- •10. Patients with immunoimpairment
- •-patients with Leucoses
- •-patients with HIV
- •-patients with any carcinoma
研究者
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