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临床试验/NCT00120835
NCT00120835已完成1 期

An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C

Merck Sharp & Dohme LLC3 个研究点 分布在 2 个国家开始时间: 2004年7月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
试验地点
3

研究概览

简要总结

This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.

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 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 genotype-1, chronic hepatitis C infection
  • •Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)
  • •Other protocol-defined inclusion criteria may apply.

排除标准

  • •Patient is pregnant
  • •Patient is co-infected with hepatitis B or HIV
  • •Other protocol-defined exclusion criteria may apply.

研究者

申办方类型
Industry

研究点 (3)

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