Protocol to Describe the Actual Situation of Hepatitis C Treatment in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,649
- 主要终点
- Mode of Hepatitis C virus (HCV) transmission
研究概览
简要总结
The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).
详细描述
This is an observational, non-interventional, cross-sectional, multicenter study to describe demographic characteristics, treatment performed and clinical outcomes of Brazilian participants with HCV chronic infection in about 12 Brazilian reference centers. It will expect that approximately 2000 participants will be enrolled in the study. Analysis set will consist of participants with HCV chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype. The study related data will be collected from the medical records in the predesigned electronic Case Report Form (eCRF).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Participants with diagnosis confirmed with Hepatitis C infection being followed into the reference centers
- •There is no restriction on fibrosis stage or clinical liver disease
- •There is no restriction for comorbities or coinfections
- •Diagnosis of chronic HCV infection detected by anti-HCV (ELISA assays), HCV Ribonucleic acid (RNA) (polymerase chain reaction [PCR] reaction) with identification of genotype
排除标准
- •Male or female participant with age greater than or equal to 18 years
- •participating in another interventional clinical trial
- •Treated participants who achieved sustained Virological Response (SVR)
结局指标
主要结局
Mode of Hepatitis C virus (HCV) transmission
时间窗: Day 1
Data will be collected through medical records of the participants. Mode of HCV transmission route (unsafe injections, hemodialysis, infection drug use, blood transfusion, sexual transmission, vertical transmission, unknown, other) will be analysed by number of participants infected with HCV per transmission route.
Number of Participants with Coinfections
时间窗: Day 1
Data will be collected through medical records of the participants.
HCV treatment status on Day 1: Number of participants treated without Sustained Virological Response (SVR)
时间窗: Day 1
Data will be collected through medical records of the participants.
HCV genotype and subtype
时间窗: Day 1
Data will be collected through medical records of the participants.
Number of participants with chronic hepatitis C infection
时间窗: Day 1
Data will be collected through medical records of the participants.
Number of Participants with chronic hepatitis C infection Reported Based on City and States
时间窗: Day 1
Data will be collected through medical records of the participants.
Number of Participants with chronic hepatitis C infection Based on precedence
时间窗: Day 1
Data will be collected through medical records of the participants.
Number of participants with chronic hepatitis C infection Reported Based on Race
时间窗: Day 1
Data will be collected through medical records of the participants.
HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
时间窗: Day 1
Data will be collected through medical records of the participants.
Liver characteristics: Number of Participants with extra hepatic manifestations
时间窗: Day 1
Data will be collected through medical records of the participants. Presence or absence of extra hepatic manifestations (cryoglobulinemia, lymphoma, Sjogren syndrome, glomerulopathy, Porphyria cutanea tarda, liquen planus, diabetes mellitus, thyroiditis, arthralgia).
Liver characteristics: Number of Participants with presence of comorbidities
时间窗: Day 1
Data will be collected through medical records of the participants. Presence of comorbidities (amount of alcohol ingestion, metabolic syndrome, hepatocellular carcinoma, organ transplantation, diabetes, immunodeficiency, renal insufficiency and dialysis, use of drugs) will be collected.
Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
时间窗: Day 1
Data will be collected through medical records of the participants.
Treatment regimen
时间窗: Day 1
The drugs used and time of treatment will be collected through medical records of the participants.
Date of last visit
时间窗: Day 1
Mean Age of Participants with chronic hepatitis C infection
时间窗: Day 1
Data will be collected through medical records of the participants.
Number of Males and Females with chronic hepatitis C infection
时间窗: Day 1
Data will be collected through medical records of the participants.
Liver characteristics: Model for End-Stage Liver Disease (MELD) Score and Child Pugh score
时间窗: Day 1
MELD is a scoring system for assessing the severity of chronic liver disease. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).
HCV treatment status on Day 1: Causes of interruption in treatment
时间窗: Day 1
Data will be collected through medical records of the participants. Causes of interruption to antiviral therapy will be collected and reported.
Number of participants with Adverse Events (AEs)
时间窗: Day 1
Duration of diagnosis of chronic hepatitis C infection
时间窗: Day 1
Data will be collected through medical records of the participants.
次要结局
未报告次要终点