A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 主要终点
- Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.
详细描述
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. The study will consist of a screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 300 participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in combination with 400 mg sofosbuvir once daily either for 12 weeks (Arm 1) or 8 weeks (Arm 2). Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 42 weeks.
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
- •Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization
- •Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
- •Documentation of the IL28B genotype before randomization
- •HCV ribonucleic acid level greater than 10,000 IU/mL at screening
- •Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
- •Absence of cirrhosis in participants
排除标准
- •Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
- •Infection/co-infection with HCV non-genotype 1a or 1b
- •Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
- •Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)
- •Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection
研究组 & 干预措施
Arm 1 (Simeprevir/Sofosbuvir)
150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
干预措施: Simeprevir (Drug)
Arm 1 (Simeprevir/Sofosbuvir)
150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
干预措施: Sofosbuvir (Drug)
Arm 2 (Simeprevir/Sofosbuvir)
150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks.
干预措施: Simeprevir (Drug)
Arm 2 (Simeprevir/Sofosbuvir)
150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks.
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
时间窗: 12 weeks after the end of treatment (EOT) (Week 20 or Week 24)
Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (\<) lower limit of quantification (LLOQ; 25 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.
次要结局
- Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24(Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24)
- Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores(Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24)
- Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale(Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24)
- Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)(4 weeks after the end of treatment (EOT) (Week 12 or Week 16))
- Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)(24 weeks after the end of treatment (EOT) (Week 32 or Week 36))
- Percentage of Participants With Viral Relapse(Up to Week 24)
- Percentage of Participants Achieving a On-treatment Virologic Response(Day 14, Day 28, End of treatment (Week 8 or Week 12))
- Percentage of Participants With Viral Breakthrough(Up to Week 24)
- Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)(Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24)