ISRCTN51477478已完成不适用
Combination therapy using pegylated interferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV) infection 3 to 120 months after liver transplantatio
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)0 个研究点目标入组 75 人开始时间: 2005年9月9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
- 75
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
- •1. Males, females above the age of 18
- •2. HCV reinfection after liver transplantation
- •3. 3 to 120 months after liver transplantation
- •4. Histology showing hepatitis
- •5. Negative pregnancy test
- •6. Willingness to give written informed consent
排除标准
- •1. Histology showing acute or chronic rejection
- •2. Hypersensivity to ribavirin, interferon
- •3. HCV-positive donor
- •4. Pretreatment with pegylated interferon plus/minus ribavirin
- •5. Pretreatment with interferon plus ribavirin
- •6. Pregnancy
- •7. Active cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis A virus (HAV) infection
- •8. Liver cirrhosis, Child Pugh stages B or C
- •9. Alpha fetoprotein >100 ng/m
- •10. Bilirubin >3.0 mg/d
- •11. Creatinine clearance <40 ml/min
- •12. Hemoglobin <10 g/dl (females), <11 g/dl (males)
- •13. Hepatocellular carcinoma within 2 months prior to randomization
- •14. Neutrophils <1500/µl
- •15. Leukozytes >11,000/µl
- •16. Platelets <75,000/µl
- •17. Patients at special risk for anemia
- •18. Patients at special risk for complications induced by anemia
- •19. Autoimmune disease
- •20. Functionally relevant chronic lung disease
- •21. Severe cardiovascular disease
- •22. Psychiatric disease, especially depression
- •23. Epilepsy
- •24. Carcinoma
- •25. Difficult to treat thyroid disease
- •26. Retinopathy
- •27. Difficult to treat diabetes mellitus
- •28. Active drug abuse, including alcohol abuse
研究者
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