A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 351
- 主要终点
- To evaluate the antiviral efficacy of response guided therapy.
研究概览
简要总结
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
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
- Double (Participant, 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
- •Males and females 18-70 years of age
- •Chronic HCV infection
- •Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
- •Monoinfection with HCV genotype 1
- •HCV RNA > 10^4 IU/mL at Screening
- •HCV treatment naïve
- •Candidate for PEG/RBV therapy
- •Body mass index (BMI) 18-36 kg/m2, inclusive
- •Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.
排除标准
- •Pregnant female or male with pregnant female partner
- •Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
- •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 resolved 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. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.
研究组 & 干预措施
Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
干预措施: peginterferon alfa-2a (Biological)
Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
干预措施: GS-5885 (Drug)
Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
干预措施: GS-9451 (Drug)
Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
干预措施: peginterferon alfa-2a (Biological)
Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
干预措施: ribavirin tablet (Drug)
Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
干预措施: GS-5885 (Drug)
Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
干预措施: ribavirin tablet (Drug)
Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
干预措施: GS-9451 Placebo (Drug)
结局指标
主要结局
To evaluate the antiviral efficacy of response guided therapy.
时间窗: Through 24 weeks post-treatment
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
次要结局
- To evaluate the safety and tolerability of each regimen.(Through 24 weeks post-treatment)
- To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.(Through Day 10 on study)
- To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.(12 or 24 weeks)
- To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.(Through 48 weeks of treatment)