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临床试验/NCT03488589
NCT03488589Unknown不适用

Hepatitis E Virus Infection Among Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver

Mahmoud Abdel Rahman0 个研究点目标入组 150 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
HEV incidence estimation among acute hepatitis patients

研究概览

简要总结

Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3 million human cases per year worldwide, with around 70,000 deaths. Most cases occur in endemic countries, but the number of cases in low-endemic areas has increased. HEV seroprevalence is high in developing countries, such as India and Southeast Asia, ranging from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and immunodeficient patients.

The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses (common in domestic and wild pigs), capable of infecting humans as an accidental host and therefore considered zoonotics.

The course and clinical presentation of hepatitis E is highly variable. The detailed mechanisms that lead to the different clinical outcomes in hepatitis E are only partially understood. It is known that both viral factors (genotype and dose of inoculum) and host factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms) determine the course of infection. In most cases, hepatitis E causes self-limited illness, lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed countries it can cause chronic disease with rapid progression to cirrhosis, especially in patients who are transplanted, have hematological malignancies requiring chemotherapy, or have infection with HIV.

Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the serum, or directly by detecting the genome of the virus in blood or other body fluids. The tests for anti-hepatitis E antibody screening are commercially available, but none of them has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity and specificity of these tests vary greatly and this could explain the discrepancies in rates of anti-hepatitis E antibodies published for the various populations studied. The tests for viral RNA in serum and feces are confirmatory, but still experimental.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level))
  • Post-transplant acute hepatitis

排除标准

  • hepatitis A, B and C patients
  • autoimmune hepatitis
  • Alcoholism
  • Treatment with hepatotoxic drugs
  • Biliary disease
  • Infection with CMV or EBV
  • Taken ribavirin therapy

结局指标

主要结局

HEV incidence estimation among acute hepatitis patients

时间窗: 1-2 years

in our university hospital HEV is underestimated due to the lack of laboratory investigation of it . so, by this study we aim to estimate the number of affected cases with HEV infection among symptomatic patients with acute hepatitis.

次要结局

  • Detection of Hepatitis E viral nucleic acid in stool and serum(1-2 years)

研究者

发起方
Mahmoud Abdel Rahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Abdel Rahman

principal investigator

Assiut University

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