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Status unknownNCT03488589Updated Jul 24, 2018

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

An observational study in Hepatitis E, sponsored by Mahmoud Abdel Rahman. Status unknown. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Mahmoud Abdel Rahman · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
150
Sex
All
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Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testserum samples for HEV RNA PCR

    serum samples HEV RNA PCR

05

What researchers measure

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.

    Time frame: 1-2 years

Secondary outcomes

  1. 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 .

    Time frame: 1-2 years

Other outcomes

  1. 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.

    Time frame: 1-2 years

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03488589
Lead sponsor
Mahmoud Abdel Rahman
Collaborators
Assiut University
Responsible party
Mahmoud Abdel Rahman (principal investigator, Assiut University) — Sponsor-investigator
First posted
Apr 5, 2018
Start date
Oct 1, 2018 (estimated)
Primary completion
Oct 1, 2019 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Jul 24, 2018

Study contacts

Mahmoud Ab Mahmoud
Contact
mam_rahman2015@yahoo.com
01064344557
Asmaa Ab Abdullah
Contact
Asmaaabdelazziz6@gmail.com
01141002390
Enas A Reda, professor
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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