NCT00034359已完成2 期
A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 4
研究概览
简要总结
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
详细描述
Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.
- •Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.
- •Hepatitis B e-antigen positive.
- •Human immunodeficiency virus negative.
- •Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).
- •No need for excluded medications.
- •Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.
排除标准
- •Human immunodeficiency virus infection.
- •Hepatitis C co-infection.
- •Concurrent systemic antiviral treatment.
- •Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.
- •Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
- •Alcohol abuse.
- •Pregnancy or breast-feeding.
- •Inability to tolerate oral medication.
- •Aspartate aminotransferase > 7.0 times the upper limit of normal.
- •Alanine aminotransferase > 7.0 times the upper limit of normal.
- •Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
- •Use of any investigational drug.
研究者
研究点 (4)
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