An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12
研究概览
简要总结
The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.
详细描述
This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Chronic hepatitis C virus (HCV)
- •Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
- •Males and females 18-65 years old
- •Body mass index 18 to < 35 kg/m^2
- •Females must be postmenopausal for at least 2 years or surgically sterile
排除标准
- •Cirrhosis or extensive bridging fibrosis
- •History of cardiac disease
- •Positive screen for certain drugs or alcohol
- •Abnormal laboratory results
- •Significant sensitivity to any drug
- •Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- •Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing
研究组 & 干预措施
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ABT-450 (Drug)
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ABT-450 (Drug)
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ABT-333 (Drug)
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ribavirin (Drug)
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ritonavir (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ABT-333 (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ribavirin (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
干预措施: ritonavir (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
干预措施: ABT-450 (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
干预措施: ABT-333 (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
干预措施: ribavirin (Drug)
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders
ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
干预措施: ritonavir (Drug)
结局指标
主要结局
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12
时间窗: Week 4 through Week 12
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (\< 15 IU/mL).
次要结局
- Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment(Post-treatment Day 1 to Post-treatment Week 24)
- Time to Failure to Suppress or Rebound During Treatment(Day 1 through Week 12)
- Time to Virologic Relapse Post-treatment(Post-treatment Day 1 to post-treatment week 48)
- Resistance-Associated Variants and Phenotypic Resistance(Day 1 to post-treatment week 48)
- Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants(Day 1 to Week 12)
- Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants(Day 1 to Week 12)
- Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants(Day 1 to Week 12)
- Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants(Day 1 to Week 12)
- Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)(Week 2)
- Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4(Week 4)
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment(Post-treatment Day 1 to Post-treatment Week 12)