An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasabuvir and Ribavirin (RBV) for 12 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
研究概览
简要总结
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.
详细描述
A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
- •Chronic HCV infection.
- •Participants must be non-cirrhotic.
- •Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
- •Participants must meet specific human leukocyte antigen (HLA) allele requirements.
排除标准
- •Women who are pregnant or breastfeeding.
- •Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
- •Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
- •Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
- •History of solid organ transplant.
- •Screening laboratory analysis that shows abnormal results.
研究组 & 干预措施
Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
干预措施: ombitasvir/paritaprevir/ritonavir (Drug)
Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
干预措施: dasabuvir (Drug)
Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV
Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID)
干预措施: ribavirin (Drug)
结局指标
主要结局
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
时间窗: Week 0 to Post-Treatment Week 12
The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as 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. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.
次要结局
未报告次要终点