HEV in Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver

NCT03488589 | Unknown

• 1 other identifier: Assiut2018
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

• HEV incidence estimation among acute hepatitis patients

  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.

  1-2 years

Secondary Outcomes (1)

• Detection of Hepatitis E viral nucleic acid in stool and serum

  1-2 years

Other Outcomes (1)

• medical recommendation

  1-2 years

Interventions

serum samples for HEV RNA PCR DIAGNOSTIC_TEST

serum samples HEV RNA PCR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients fulfilling the inclusion criteria of acute hepatitis either admitted to Al-Rajhi University hospital for liver,visiting Al-Rajhy university hospital outpatient clinics for gastroentrology and hepatology or consultations from other departments at Assiut University hospitals

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahmoud Abdel Rahman: lead
• Assiut University: collaborator

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Enas A Reda, professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mahmoud Ab Mahmoud

CONTACT

01064344557; mam_rahman2015@yahoo.com

Asmaa Ab Abdullah

CONTACT

01141002390; Asmaaabdelazziz6@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE