A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 248
- 试验地点
- 54
- 主要终点
- Sustained virologic response (SVR)
研究概览
简要总结
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18-70 years of age
- •Chronic HCV infection
- •Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
- •Monoinfection with HCV genotype 1a or 1b
- •HCV RNA > 10^4 IU/mL at Screening
- •IL28B CC genotype
- •HCV treatment naïve
- •Candidate for PEG/RBV therapy
- •Body mass index (BMI) between 18 and 36 kg/m2
- •Creatinine clearance >= 50 mL/min
- •Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
排除标准
- •Exceed defined thresholds for key laboratory parameters at Screening
- •Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
- •Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
- •Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
研究组 & 干预措施
Arm 1
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
干预措施: PEG (Drug)
Arm 1
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
干预措施: RBV (Drug)
Arm 1
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
干预措施: GS-9451 (Drug)
Arm 1
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
干预措施: GS-5885 (Drug)
Arm 2
Response-Guided Therapy with PEG and RBV for 24 weeks.
干预措施: RBV (Drug)
Arm 2
Response-Guided Therapy with PEG and RBV for 24 weeks.
干预措施: PEG (Drug)
结局指标
主要结局
Sustained virologic response (SVR)
时间窗: 30 , 36 or 48 weeks
Sustained virologic response (SVR, defined as plasma HCV RNA \< lower limit of quantification \[LLoQ\] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
次要结局
- Safety and tolerability of therapy(Up to 48 weeks)
- Virologic response(Weeks 2, 4, 6, 8, 10, and 12)
- Compare SVR(Weeks 30 and 36)
- Viral resistance(Up to 96 Weeks)