A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 5
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
研究概览
简要总结
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and 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
- Triple (Participant, Care Provider, Investigator)
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
- •Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- •No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
- •Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- •Males and females, 18 - 70 years of age
排除标准
- •Liver transplant recipients
- •Documented or suspected hepatocellular carcinoma
- •Evidence of decompensated cirrhosis
- •History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
- •Current or known history of cancer
- •Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
- •Inability to tolerate oral medication
- •Poor venous access
- •Severe psychiatric disease
- •History of chronic pulmonary disease
- •History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
- •History of or current electrocardiogram findings indicative of cardiovascular instability
- •Preexisting ophthalmologic disorders considered clinically significant on eye
- •History of uncontrolled diabetes mellitus
- •Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
- •Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
- •Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
- •Exposure to any investigational drug or placebo
研究组 & 干预措施
Control
Placebo + Pegylated interferon alfa-2a + Ribavirin
干预措施: Placebo (Drug)
Control
Placebo + Pegylated interferon alfa-2a + Ribavirin
干预措施: Pegylated interferon alfa-2a (Drug)
Control
Placebo + Pegylated interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
12 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Daclatasvir (Drug)
12 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Pegylated interferon alfa-2a (Drug)
12 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
16 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Daclatasvir (Drug)
16 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Pegylated interferon alfa-2a (Drug)
16 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
时间窗: Follow-up Week 24
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
时间窗: Follow-up Week 24
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
次要结局
- Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2(Week 4)
- Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3(Week 4)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period(Baseline (Day 1) up to 24 weeks (treatment period))
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period(From end of treatment period up to Week 48 (follow-up period))
- Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2(Week 12)
- Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3(Week 12)
- Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2(Follow-up Week 12)
- Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3(Follow-up Week 12)
- Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2(Baseline up to Week 48)
- Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3(Baseline up to Week 48)