A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 主要终点
- Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
研究概览
简要总结
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.
详细描述
This is a open-label (all people know the identity of the intervention), single arm, multicenter study. The study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. 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 40 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 1 infection (confirmed at screening).
- •HCV ribonucleic acid (RNA) 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
- •Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
- •Participant must be willing and able to comply with the protocol requirements
- •Participants with liver cirrhosis
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 1
- •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)
100 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)
100 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)
结局指标
主要结局
Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
时间窗: Week 24
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.
次要结局
- Percentage of Participants With Viral Relapse(During the Follow-up (Week 24))
- Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24(Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24)
- Percentage of Participants With On-treatment Virologic Response(Week 2, 4 and End of Treatment (Week 12))
- Percentage of Participants With On-treatment Failure(Week 12)
- Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24(Baseline, Follow-up Week 12 and 24)
- Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)(Week 16)
- Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)(Week 36)
- Percentage of Participants With Viral Breakthrough(Up to End of Treatment (Week 12))
- Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12(Baseline, Week 4, Week 12 and Follow-Up Week 12)
- Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24(Baseline, Week 12, Follow-up Week 12 and 24)
- Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, Week 12, Follow-up Week 12 and 24)