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临床试验/NCT03693586
NCT03693586已完成不适用

Study to Determine the Hepatitis C Virus Infection Prevalence Among Patients Attended Primarily for Vasculitis and Other Potential Extrahepatic Manifestations

Hospital General de Mexico1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
seropositive for hepatitis C

研究概览

简要总结

Chronic hepatitis C infection (CHC) is usually asymptomatic; nevertheless, there are studies that show that up to two thirds of patients may present some type of extrahepatic manifestation. The most frequent extrahepatic manifestation is type II mixed cryoglobulinemia (MCG-II) and clinically the most common presentation is leukocytoclastic vasculitis (LCV) with palpable purpura that affects the lower extremities. It is estimated that up to 80% of MCG-II cases are due to CHC. Also, previous studies have demonstrated that CHC prevalence is higher in patients with autoimmune diseases compared with general population. Therefore, if vasculitis is an extrahepatic manifestation of CHC, then the prevalence of CHC infection in this group of patients could be higher than the prevalence reported in general population.

The aim of the study is to know the prevalence of CHC, determined by serological rapid test for hepatitis C screening, then all positive cases will be confirmed by quantitative viral load, in patients who consult primarily to a rheumatology department for "vasculitis" or other potential hepatitis C extrahepatic manifestations (rheumatological conditions).

详细描述

  1. Introduction.

The prevalence of Hepatitis C determined by serological test to detect antibodies against the hepatitis C virus (HCV) is around 1.4% in Mexico, being slightly higher in the north (2.0%) than in the south (1.5%). ) and the entities of the center (1.1%) of the country. However, there are high risk groups where the prevalence is much higher, for example, among intravenous drug users such as heroin, it is estimated that prevalence of hepatitis C is as high as 11.7%, with an interval ranging from 2.7 to 39.1% .

Recently, the Global Prevalence study of HCV - Polaris Observatory at American Association for de the Study of Liver (AASLD), has documented that the prevalence in Mexico determined by viral load quantification (which is the most specific study) ranges from 0.0 to 0.6%, being higher in the North, than in the Center and in the South of the country.

Although it is classically considered that chronic hepatitis C infection (CHC) is usually asymptomatic, there are studies that show that up to two thirds of patients may present some type of extrahepatic manifestation. The most frequent extrahepatic manifestation is type II mixed cryoglobulinemia (MCG-II) and clinically the most common presentation is leukocytoclastic vasculitis (LCV) with palpable purpura that affects the lower extremities. It is estimated that up to 80% of MCG-II cases are due to CHC. The prevalence of CHC infection has been reported in higher numbers in patients with LCV than in the general population. A multinational study in 2009, found that the prevalence of anti-HCV antibodies specifically in patients consulting for "autoimmune diseases" was as high as 8.7%, compared to healthy subjects (general population) where it was 0.4%. In this study, the diagnosis of CHC with determination of viral load or genotype was not confirmed.

In another study, conducted in Brazil, which included 367 patients with rheumatological diseases, the prevalence of CHC, confirmed with viral load determination, was 1.9%, also higher than that reported in the open population in that country. The difference remarkable in the prevalences reported by serological tests and by viral load, particularly in patients with autoimmune diseases, can be explained because patients with autoimmune diseases have autoantibodies that can generate cross reactions and result in false positives, for this reason, in the presence of a positive result in these tests, must always be confirmed with the gold standard that is the quantification of viral load. 2. Research question.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • patients who primarily consults to a rheumatology department for vasculitis and agree to be evaluated through a questionaire to identify risk factors for hepatitis C and who also agree to be screened with a serological rapid test for hepatitis C.

排除标准

  • patients who decline to participate

结局指标

主要结局

seropositive for hepatitis C

时间窗: 1 year

serological rapid test screening for hepatitis C

次要结局

  • confirmation of a hepatitis C case(1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

MARIA DE FATIMA HIGUERA DE LA TIJERA

Head of Gastroenterology and Hepatology Department

Hospital General de Mexico

研究点 (1)

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