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 人开始时间: 2009年12月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 231
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32189364/ (added 27/10/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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
- •5.6. Ascites
- •6. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., haemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassaemia)
- •7. Signs or symptoms of hepatocellular carcinoma. Patients with a value of alpha-fetoprotein greater than 100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months. Patients with values greater than 20 ng/mL but less than or equal to 100 ng/mL may be enrolled, if hepatic neoplasia has been excluded by liver imaging
- •8. Neutrophil count less than 1500 cells/mm^3 or platelet count less than 90,000 cells/mm^3 at screening
- •9. Haemoglobin less than 11.5 g/dL for females and less than 12.5 g/dL for men at screening
- •10. Serum creatinine level greater than 1.5 x ULN at screening
- •11. Phosphorus less than 0.65 mmol/L
- •12. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquiliser at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicide attempt, hospitalisation for psychiatric disease, or a period of disability due to a psychiatric disease.
- •13. History of a severe seizure disorder or current anticonvulsant use
- •14. History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, psoriasis, rheumatoid arthritis etc.)
- •15. History of chronic pulmonary disease associated with functional limitation
- •16. History of severe cardiac disease (e.g. New York Heart Association [NYHA] Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing
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