NCT03235349已完成3 期
An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
AbbVie34 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2017年9月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 34
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.
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
- •Must be of Asian descent.
- •Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
- •Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL at Screening Visit.
- •Chronic HCV infection defined as one of the following:
- •Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
- •A liver biopsy consistent with chronic HCV infection;
- •HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN] with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed >= 8 weeks prior to screening.
- •Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening and no current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites noted on physical exam, bleeding varices, use of diuretics for ascites, or hepatic encephalopathy.
- •Absence of hepatocellular carcinoma (HCC)
- •Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
- •Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening.
- •Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ % >= 29%), or
- •On a stable, qualifying HIV-1 ART regimen with CD4+ count >= 200 cells/mm³ (or CD4+ % >= 14%) at Screening; and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.
排除标准
- •Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
- •Any cause of liver disease other than chronic HCV-infection.
- •HCV genotype performed during screening indicating co-infection with more than one HCV genotype
- •Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
- •Chronic human immunodeficiency virus, type 2 (HIV-2) infection
- •Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
- •For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
- •Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
- •Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.
研究组 & 干预措施
Glecaprevir/Pibrentasvir
Experimental
Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
干预措施: Glecaprevir/Pibrentasvir (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, Week 24 or Week 28 depending on the treatment regimen.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
次要结局
- Percentage of Participants With Post-treatment Relapse(From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).)
- Percentage of Participants With On-treatment Virologic Failure(12 or 16 weeks depending on the treatment regimen)
- Percentage of HCV/HIV Co-infected Participants Achieving SVR12(12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen)
研究者
研究点 (34)
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