NCT01193361已完成2 期
A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Bristol-Myers Squibb10 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 10
- 主要终点
- Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
研究概览
简要总结
At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
- •HCV RNA ≥ 10*5* IU/mL at Screening
- •Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
- •Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
- •Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening
排除标准
- •Liver transplant recipients
- •Documented or suspected HCC by imaging or liver biopsy
- •Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- •History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
- •Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
研究组 & 干预措施
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: Ribavirin (Drug)
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: BMS-791325 (Drug)
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: Peg-interferon alfa-2a (Drug)
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: Ribavirin (Drug)
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: BMS-791325 (Drug)
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Experimental
干预措施: Peg-interferon alfa-2a (Drug)
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Placebo Comparator
干预措施: Placebo (Drug)
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Placebo Comparator
干预措施: Peg-interferon alfa-2a (Drug)
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Placebo Comparator
干预措施: Ribavirin (Drug)
结局指标
主要结局
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
时间窗: Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
时间窗: Week 12
次要结局
- Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA(Week 12)
- Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up(Week 24)
- Resistant HCV variants associated with virologic failure(End of treatment (Week 48) or upon early discontinuation)
- Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA(Week 4)
研究者
研究点 (10)
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