Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 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 safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.
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
- •Male or female, at least 18 years of age at time of screening
- •Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection
- •Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
- •Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening
- •A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites
- •Documented complete response to HCC treatment.
- •Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.
排除标准
- •Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
- •Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- •Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.
- •Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.
研究组 & 干预措施
OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without 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, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
干预措施: ombitasvir/paritaprevir/ritonavir and dasabuvir (Drug)
OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without 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, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
干预措施: ombitasvir/paritaprevir/ritonavir (Drug)
OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks
OBV/PTV/r (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) with or without 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, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.
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 after flanking imputation were imputed as nonresponders.
次要结局
- Percentage of Participants With Recurrent HCV Infection Post Liver Transplant(from liver transplant to 24 weeks post-treatment (up to 48 weeks))
- Percentage of Participants With On-treatment Virologic Failure(Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-week treatment))
- Percentage of Participants With Long Term Clinical Outcomes(up to 48 weeks)
- Percentage of Participants With Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)