NCT00115908已完成2 期
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 173
- 主要终点
- Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
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
- •Interferon treatment naive subjects with chronic hepatitis C, HCV genotype
- •Compensated liver disease
排除标准
- •Pregnant or lactating female or males with a pregnant partner.
- •A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
- •A history of moderate, severe or uncontrolled psychiatric disease.
- •A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.
结局指标
主要结局
Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.
次要结局
- Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
- Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
- Undetectable HCV RNA at Week 24.
- End of treatment response (ETR), defined as undetectable HCV RNA at Week 48
研究者
研究点 (173)
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