The Epidemiology of Hepatitis E Virus Infection in Israel and Potential Risk Factors

NCT02419625 | Unknown

• 1 other identifier: CMC-15-0021-CTIL
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatitis E virus is a single-stranded positive-sense RNA virus with genome of approximately 7.2kb in length. The HEV genome is capped at the 5' end followed by a small untranslated region of 27 nucleotides and polyadenalated at the 3' end preceded by another UTR of 65 nucleotides . HEV has three open reading frames: ORF1, ORF2 and ORF3 that encode structural and non- structural proteins. ORF1 is the largest one, approximately 5,000 nt in length, located at the 5 ' end and encodes important proteins for the replication process (methyltransferase, papain-like cysteine protease, helicase, and RNA-dependent RNA polymerase). A noncoding, hypervariable region within ORF1 displays substantial genetic diversity; this region seems to modulate the efficiency of HEV replication. Notably, the differences in the genome size among different HEV strains are confined mainly to this region .ORF2 is located at the 3' end, encodes structural capsid proteins of 660 amino acids and contains three potential glycosylation sites. The ORF2 protein contains multiple immunogenic sites and neutralizing antibodies are directed against it al., .The essential region in the protein for immunogenicity is 452aa-617aa and the neutralizing epitopes have recently been shown to be conformational .ORF3 is located between the other two reading frames and encodes a small phosphoprotein of 123 amino acids. Its exact function has not been yet determined, however, multiple functions have been proposed. It is thought to interact with cellular mitogen-activated protein kinase phosphatase and other extracellular kinases, promoting cell survival through activation of intracellular signaling pathways .Moreover, the binding of the ORF3 encoded protein to host-specific proteins seems to influence the pathogenesis of HEV infections .A schematic drawing of the HEV genome is described in Figure 1 .

Conditions

Chronic Hepatitis E

Outcome Measures

Primary Outcomes (1)

• study will measure the frequency of HEV infection in immune compromised population and in subjects with unexplained elevation of liver enzymes

  2 years

Study Arms (1)

subgroup-specific HEV in Israel

OTHER

The study will involve patient interviews using questionnaires

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

questionnaires , serum samples will be used

subgroup-specific HEV in Israel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with elevated liver enzymes of unknown etiology
• Patients with acute hepatitis of unknown etiology
• Patients with chronic infection with hepatitis B , D or C.
• Immunosuppressed patients: patients with solid or haemato-oncologic malignancy or patients with chronic HIV infection.
• Patients with chronic liver disease of unknown etiology
• Participants who have contacts with swines: delivery, feeding, slaughtering, treatment)
• Healthy volunteers.

You may not qualify if:

• Participants who do not fill the above criteria
• Participants who are not willing to sign an inform consent
• Participants younger than 18 year old

Sponsors & Collaborators

• Carmel Medical Center: lead

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• eli zuckerman

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of liver unit

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: April 17, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 21, 2016

Record last verified: 2016-07