NCT00037622终止不适用
An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
研究概览
简要总结
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
详细描述
Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies.
- •Adults ? 18 years of age
- •Chronic HBV infection, known to be HbsAg positive ? 6 months
- •Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study
- •Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment
- •HIV negative
- •Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
- •No need for excluded medications
- •Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal)
- •Exclusion Criteria
- •HIV infection
- •Active Hepatitis C co-infection
- •Concurrent systemic antiviral treatment
- •Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443
- •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
- •AST>10.0 times the upper limit of normal
- •ALT>10.0 times the upper limit of normal
- •Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements
- •Use of investigational drug not approved by Medical Monitor
排除标准
- 未提供
研究者
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