NCT00395421已完成2 期
A Partially-blinded, Randomized, Parallel-group Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between Valopicitabine and Ribavirin When Administered in Combination With Pegylated Interferon Alfa-2a in Treatment-naive Patients With Chronic Hepatitis C
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
研究概览
简要总结
This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- •Has not previously received anti-viral therapy for hepatitis C infection
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding
- •Patient is co-infected with hepatitis B virus and/or HIV
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
A
Experimental
NM283(200 mg QD)plus Peg-IFNα-2a (180 µg QW)
干预措施: NM283 plus Peg-IFNα-2a (Drug)
研究者
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