ACTRN12610001101077招募中4 期
A randomized, open-label, controlled, multi-centre pilot study evaluating the efficacy and safety of Tenofovir 300 mg PO in combination with peginterferon alpha-2a subcutaneous 180 micrograms for 48 weeks in patients with HBeAg-positive CHB
Dr Anouk Dev0 个研究点目标入组 75 人开始时间: 2010年12月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Documented Chronic Hepatitis B defined by all of the following:
- •1.Clinical history compatible with CHB
- •2.Detectable serum HBsAg at the Screening visit and at least 6 months prior
- •3.HBeAg-positive and HBeAb-negative at the Screening visit
- •4.History of evidence of chronic liver inflammation, documented by previous history of elevated serum ALT (at least two documented elevated ALT values spanning six months or more))
- •5.Elevated serum ALT level (1.1 – 10 x upper limit of normal (ULN)) at the Screening visit
- •6.Serum HBV DNA level = 3 log10 IU/mL at the screening visit
- •7.Chronic liver inflammation on a liver biopsy performed within the previous 5 years
排除标准
- •1.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •2.Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
- •3.Has had any of the following drug therapy:
- •*Received nucleoside or nucleotide therapy whether approved or investigational in the three months before screening for this study.
- •*Received conventional interferon alpha or other immunomodulatory therapies in the six months before screening for this study.
- •*Has previously received Pegylated Interferon alpha at any stage for the treatment of CHB
- •4.Has a medical condition that requires frequent or prolonged use of systemic corticosteroids although inhaled or intra-articular corticosteroids are allowed.
- •5.Has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
- •6.Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 12 months.
研究者
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