ISRCTN79659320
已完成
未知
A randomised open label study evaluating the efficacy and safety of peginterferon alpha-2a (40KD) (PEGASYS®) or adefovir dipivoxil in patients with lamivudine-resistant HBeAg positive chronic hepatitis B
Shanghai Roche Pharmaceuticals Ltd (China)0 个研究点目标入组 231 人2009年12月7日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic hepatitis B
- 发起方
- Shanghai Roche Pharmaceuticals Ltd (China)
- 入组人数
- 231
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32189364/ (added 27/10/2022)
研究者
入排标准
入选标准
- •1\. Male and female patients aged greater than or equal to 18 years and less than or equal to 65 years
- •2\. Hepatitis B surface antigen (HBsAg) positive, hepatitis B 'e' antigen (HBeAg) positive for at least 6 months, and anti\-HBs negative
- •3\. Treatment with lamivudine for at least 6 months and ongoing
- •4\. Laboratory or clinical signs of lamivudine resistance (for example hepatitis B virus deoxyribonucleic acid \[HBV DNA] rebound greater than 100,000 copies/mL and/or alanine aminotransferase \[ALT] flares)
- •5\. Lamivudine resistant in terms of YMDD mutant HBV detection (INNO\-LiPA method)
- •6\. ALT greater than upper limit of normal (ULN) but less than or equal to 10 x ULN, on at least two occasions taken greater than or equal to 14 days apart in the previous 6 months. At least one test should be performed after signing the consent form.
- •7\. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24\-hour period prior to the first dose of test drug. Additionally, all females must be using reliable contraception during the study and for 3 months after treatment completion.
- •8\. No evidence of cirrhosis as confirmed by liver biopsy taken in the previous 6 months
排除标准
- •1\. Patients who had previously received treatment with adefovir dipivoxil or other drugs with activity against HBV within the prior 6 months, except for lamivudine
- •2\. Antiviral, anti\-neoplastic or immuno\-modulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of randomised treatment (except for less than or equal to 7 days of acyclovir for herpetic lesions more than 1 month prior to first administration of randomised treatment). Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation are also excluded.
- •3\. Women with ongoing pregnancy or breast feeding
- •4\. Co\-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
- •5\. Evidence of decompensated liver disease (Child\-Pugh score greater than 5\). Child\-Pugh greater than 5 means, if one of the following five conditions are met, the patient has to be excluded:
- •5\.1\. Serum albumin less than 35 g/L
- •5\.2\. Prothrombin time greater than or equal to 4 seconds prolonged
- •5\.3\. Serum bilirubin greater than 34 µmol/L
- •5\.4\. History of encephalopathy
- •5\.5\. History of variceal bleeding
结局指标
主要结局
未指定
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