ISRCTN83587695已完成不适用
A multicenter randomised study comparing the efficacy of adefovir dipivoxil versus pegylated interferon alpha-2a plus placebo versus adefovir dipivoxil plus peglyated interferon alpha-2a for the treatment of chronic delta hepatitis
Hannover Medical School (MHH) (Germany)0 个研究点目标入组 69 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
- 69
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. Age >18 years
- •2. Positive Hepatits B surface Antigen (HBsAg)
- •3. Positive anti-hepatitis D virus (HDV) antibodies
- •4. Positive HDV-Ribonucleic Acid (RNA) by Polymerase Chain Reaction (PCR)
- •5. Serum alanine aminotransferase (ALT) >upper limit of normal (ULN) but <10 x ULN
- •6. Liver biopsy demonstrating liver disease consistent with chronic heaptitis
- •7. Liver imaging for patients with cirrhosis or marked fibrosis to rule out hepatic carcinoma
- •8. Negative urine or serum pregnancy test
- •9. Willingness to give written informed consent
排除标准
- •1. Antiviral therapy in previous six months
- •2. Positive tests for hepatitis A virus (HAV) Immunoglobulin M (IgM) antibodies, hepatitis C virus (HCV) RNA or HCV antibodies or Human Immunodeficiency Virus (HIV) antibodies
- •3. Serum total bilirubin >2 x ULN
- •4. Decompensated liver disease Child B-C
- •5. Other reasons for chronic liver disease
- •6. Haemoglobin <11.5 g/dl for females and <12.5 g/dl for males
- •7. White blood cell count (WBC) <3000 cells/mm^3
- •8. Serum creatinine >1.5 x ULN
- •9. Relevant psychiatric diseases
- •10. Drug or alcohol abuse within one year of entry
- •11. Other evidence or histroy of severe illness
- •12. Thyroid disease poorly controlled
- •13. Alphafetoprotein (AFP) >100 ng/ml
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