An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 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
- 10
- 主要终点
- The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
详细描述
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
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
- •Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to <38 kg/m
- •Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
- •Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
- •Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
排除标准
- •History of severe, life-threatening or other significant sensitivity to any drug.
- •Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
- •Prior therapy for the treatment of HCV.
- •Any current or past clinical evidence of cirrhosis.
- •Any cause of liver disease other than chronic HCV-infection.
- •HCV genotype co-infection with any other HCV genotype.
- •Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
研究组 & 干预措施
ABT-450/r and ABT-530 plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
干预措施: ABT-450/ritonavir (r) (Drug)
ABT-450/r and ABT-530 plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
干预措施: ABT-530 (Drug)
ABT-450/r and ABT-530 plus RBV
ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
干预措施: Ribavirin (RBV) (Drug)
结局指标
主要结局
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
时间窗: 12 weeks after last dose of study drug
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
次要结局
- The Percentage of Subjects With Virologic Failure During Treatment(Up to Treatment Week 12)
- The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)(24 weeks after last dose of study drug)
- The Percentage of Subjects With Post-Treatment Relapse(Within 12 weeks after the last dose of study drug)