An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
详细描述
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.
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
- •Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
- •Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
- •HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
- •Screening laboratory result indicating HCV genotype 1b-infection.
- •Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.
排除标准
- •Women who are pregnant or breastfeeding.
- •Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
- •Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
- •Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
- •Use of contraindicated medications within 2 weeks of dosing
- •Screening laboratory analyses showing any of the following abnormal laboratory results:
- •Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
- •Albumin < 2.8 g/dL
- •International normalized ratio (INR) > 1.
- •Participants with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
- •Hemoglobin < 10 g/dL
- •Platelets < 25,000 cells per mm3
- •Total bilirubin > 3.0 mg/dL
研究组 & 干预措施
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks
干预措施: Ombitasvir/Paritaprevir/Ritonavir (Drug)
Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks
干预措施: Dasabuvir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
时间窗: Post-treatment Day 1 to Post-treatment Week 12
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
次要结局
- Percentage of Participants With Post-Treatment Relapse(Post-treatment Day 1 to Post-treatment Week 12)
- Percentage of Participants With On-Treatment Virologic Failure(Day 1 through Week 12)