NCT00230503已完成2 期
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 主要终点
- - Safety: Clinical examinations of laboratory tests
研究概览
简要总结
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
详细描述
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
- Determine the pharacokinetic profiles of four oral doses of pradefovir
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Compensated chronic HBV Infection
- •No prior treatment with adefovir dipivoxil
- •No interferon or lamivudine treatment for three months prior to enrollment
- •HBeAg positive or negative
- •HBV DNA viral load greater than 500,000 copies per mL
- •ALT between 1.2 and 10 times ULN
排除标准
- •Positive HIV, HCV, and/or HDV serology
- •History of renal tubular necrosis
- •Serum creatinine greater than 2.0 mg/dl
- •History of organ transplant or use of immunosuppresive drugs
- •Pregnant or breast-feeding females
结局指标
主要结局
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time
次要结局
- - Efficacy: Proportion of patients with undetectable viral load
研究者
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