NCT01058512已完成2 期
A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin
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
- 22
- 试验地点
- 6
- 主要终点
- To evaluate changes in viral load
研究概览
简要总结
The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A serum HCV RNA level of >100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = ~650 IU/ml) or other equally sensitive quantitative methods.
- •Infection with genotype 1 HCV
- •Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C
- •Adequate laboratory parameters
- •Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
- •Sexually active male subjects are practicing acceptable methods of contraception during trial participation
- •Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
- •The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
排除标准
- •Clinical, laboratory, or histological evidence of liver cirrhosis
- •Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
- •Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)
- •Have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment
- •Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
- •Pregnant female or nursing mother
研究组 & 干预措施
Single
Experimental
single-arm study
干预措施: NOV-205 (Drug)
结局指标
主要结局
To evaluate changes in viral load
时间窗: 16 months
To evaluate changes in serum ALT and AST levels
时间窗: 16 months
To establish the safety profile of NOV-205
时间窗: 16 months
To evaluate the durability of any changes in viral load and serum ALT and AST
时间窗: 16 months
次要结局
未报告次要终点
研究者
研究点 (6)
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