Mapping Natural Polymorphisms of Hepatitis C Virus NS3/4A Protease and NS5A Region Among Brazilian Chronic Patients (MAPPING)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 主要终点
- Number of Participants With HCV NS3/4a Protease and NS5A Protein
研究概览
简要总结
The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.
详细描述
This is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection. Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants mono infected with chronic Hepatitis C infection (genotype 1), including naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin)
- •There is no restriction on fibrosis stage or clinical liver disease
- •There is no restriction for comorbidities
- •Male or female participants with age >=18 years
排除标准
- •Participants failed to triple therapy using protease inhibitors
- •Participants with co-infections (i.e. Human immunodeficiency virus, Hepatitis B virus)
- •Participants that are not agree to sign the written informed consent
- •Participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by Johnson & Johnson
结局指标
主要结局
Number of Participants With HCV NS3/4a Protease and NS5A Protein
时间窗: Day 1
After extraction of HCV RNA from collected blood samples, the sequences of the NS3/4A and NS5A genes of HCV will be amplified by reverse transcription polymerase chain reaction (RTPCR) using specific primers for each genomic region. PCR products will be sequenced subsequently by direct sequencing. Detection of natural polymorphisms will be analyzed a comparison of the each sequence with the subtype consensus sequence.
次要结局
未报告次要终点