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

Hepatitis E Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03488589
• Other study ID #: Assiut2018
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: Mahmoud Ab Mahmoud
• Phone: 01064344557
• Email: mam_rahman2015[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• • 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

Exclusion Criteria:

• hepatitis A, B and C patients

• autoimmune hepatitis

• Alcoholism

• Treatment with hepatotoxic drugs

• Biliary disease

• Infection with CMV or EBV

• Taken ribavirin therapy

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E

Intervention

Diagnostic Test:
• serum samples for HEV RNA PCR
serum samples HEV RNA PCR

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mahmoud Abdel Rahman	Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	medical recommendation	if our study found high incidence of HEV among patients with acute hepatitis , we can then recommend (with evidence) adding Acute HEV infection testing modalities as a routine investigation to AL-Rajhy hospital protocols in managing Acute hepatitis patients.	1-2 years
Primary	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	Detection of Hepatitis E viral nucleic acid in stool and serum	Detection of Hepatitis E viral nucleic acid in stool and serum of acute non- A, B or C hepatitis patients and compare between the viral load in both samples. and according the results we can recommend the preferred sample type to be used later for detection of the virus .	1-2 years