PER-017-99已完成未知
A PHASE II STUDY OF THE SAFETY AND ANTIVIRAL ACTIVITY OF ENTECAVIR (BMS-200475) VS LAMIVUDINE TN ADULTS WITH CHRONIC HEPATITIS B INFECTIO
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •Males and females ≥16 years of age with chronic hepatitis B (or the minimum age required for participation in a given country, whichever is higher).
- •Documentation of HBsAg positive in serum for ≥ 24 weeks prior to randomization.
- •Both HBeAg positive and HBeAg negative subjects are eligible. Those subjects who are positive for HBeAg must have been documented to be positive for ≥ 12 weeks prior to randomization; subjects negative for HBeAg must also be positive for e antibody.
- •Positive HBV DNA assay with valué > 40 MEq/mL (143 pg/mL) by the Chiron bDNA hybridization assay) on 2 determinations drawn at least 2 weeks apart.
- •ALT (SGPT) in the range of normal to 10 x ULN.
- •Total serum bilirubin ≤ 2.5 mg/dL (< 42.75 µmol/L).
- •Prothrombin time ≤ 3 seconds longer than normal control value or INR ≤ 2.23.
排除标准
- •Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV).
- •Decompensated liver disease (i.e., hepatic encephalopathy, significant ascites, bleeding varices).
- •Prior therapy with adefovir, lamivudine or lobucavir of > 12 weeks duration.
- •These drugs must have been stopped at least 24 weeks prior to randomization into this study.
- •Therapy with alpha interferon or thymosin alpha-1 within 24 weeks prior to randomization.
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