An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- •Males must be surgically sterile or agree to practice acceptable forms of birth control
- •Chronic hepatitis C virus (HCV) infection at screening
- •Fibrosis stage F3 or greater, documented by acceptable tests
- •Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods
排除标准
- •Women who are pregnant or breastfeeding
- •Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
- •Use of contraindicated medications within 2 weeks of dosing
- •Clinically significant abnormalities or co-morbidities
- •History of solid organ transplant
- •Abnormal laboratory tests
- •Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
研究组 & 干预措施
3-DAA ± RBV
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
3-DAA ± RBV
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
干预措施: ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.
次要结局
- Percentage of Participants With SVR12 by Fibrosis Stage(12 weeks after the last actual dose of study drug)
- Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening(12 weeks after the last actual dose of study drug)
- Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience(12 weeks after the last actual dose of study drug)
- Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug(Day 1 (Baseline), 12 weeks after the last actual dose of the study drug)
- Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug(Day 1 (Baseline), 12 weeks after the last actual dose of the study drug)
- (SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug(Day 1 (Baseline), 12 weeks after the last actual dose of the study drug)