A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
研究概览
简要总结
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
详细描述
The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between 18 and 65 years, inclusive, at time of Screening
- •Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
- •Subject has never received antiviral treatment for hepatitis C infection
- •Chronic HCV Genotype-1 infection prior to study enrollment
排除标准
- •Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab)
- •Females who are pregnant or plan to become pregnant, or breastfeeding
- •Any current or past clinical evidence of cirrhosis
- •Screening laboratory analyses that showing abnormal laboratory results
- •Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV
- •Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
- •Positive screen for drugs or alcohol
研究组 & 干预措施
Arm A: 3-DAA + RBV in GT1a
ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in GT1a)
干预措施: ABT-450/r/ABT-267, ABT-333 (Drug)
Arm A: 3-DAA + RBV in GT1a
ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in GT1a)
干预措施: Ribavirin (Drug)
Arm B: TPV/PR in GT1a
Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
干预措施: Ribavirin (Drug)
Arm B: TPV/PR in GT1a
Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
干预措施: Telaprevir (Drug)
Arm B: TPV/PR in GT1a
Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
干预措施: Pegylated Interferon alpha 2-a (PegIFN) (Drug)
Arm C: 3-DAA + RBV in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
干预措施: ABT-450/r/ABT-267, ABT-333 (Drug)
Arm C: 3-DAA + RBV in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
干预措施: Ribavirin (Drug)
Arm D: 3-DAA in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
干预措施: ABT-450/r/ABT-267, ABT-333 (Drug)
Arm E: TPV/PR in GT1b
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
干预措施: Ribavirin (Drug)
Arm E: TPV/PR in GT1b
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
干预措施: Telaprevir (Drug)
Arm E: TPV/PR in GT1b
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
干预措施: Pegylated Interferon alpha 2-a (PegIFN) (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
时间窗: 12 weeks after the last actual dose of active study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants With SVR12 - Secondary Efficacy Analyses(12 weeks after the last actual dose of active study drug)
- Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)(From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E)
- Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)(From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E)
- Percentage of Participants With Virologic Failure During Treatment(12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E)
- Percentage of Participants With Post-treatment Relapse(Within 24 weeks post treatment)
- Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)(24 weeks after the last actual dose of active study drug)