NCT04670419

Brief Summary

Hepatitis E Virus (HEV) infections are emerging in the Western world with a predominance of HEV genotype (gt) 3. Except for age older than 50 years, male gender, chronic liver disease and immunosuppressed status, no correlators with clinical outcomes have been identified so far. With this study, we want to examine viral factors associated with the morbidity and mortality of HEV infections in Belgium as well as find correlators with clinical outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

8.5 years

First QC Date

December 9, 2020

Last Update Submit

December 9, 2020

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

  • HEV viral factors associated with morbidity and mortality

    Viral factors, such as genotype, subtype and viral load, associated with the morbidity and mortality of HEV infections in Belgium

    observation period 2010-2018

Secondary Outcomes (1)

  • Host factors associated with the morbidity and mortality of HEV infections in Belgium.

    observation period 2010-2018

Other Outcomes (1)

  • independent host and/or viral factors associated with the morbidity and mortality of HEV infections in Belgium

    observation period 2010-2018

Study Arms (2)

HEV gt 3 clade abchijklm

patients infected with HEV gt 3 clade abchijklm

Other: Viral clade

HEV gt 3 clade efg

patients infected with HEV gt 3 clade efg

Other: Viral clade

Interventions

Viral cladeOTHER

Disease outcomes are compared for patients infected with 2 different clades of a HEV gt 3 infection

HEV gt 3 clade abchijklmHEV gt 3 clade efg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a confirmed or possible HEV infection at Sciensano between January 2010 up to and included June 2018.

You may qualify if:

  • HEV RNA positive AND/OR HEV immunoglobulin (Ig)M positive
  • Lab confirmation of the HEV infection performed at Sciensano
  • All ages will be included
  • Referring hospital in Belgium

You may not qualify if:

  • No confirmation of HEV serology AND/OR polymerase chain reaction (PCR) performed at Sciensano
  • Cases not diagnosed in Belgium
  • Cases without clinical outcome data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Peeters M, Schenk J, De Somer T, Roskams T, Locus T, Klamer S, Subissi L, Suin V, Delwaide J, Starkel P, De Maeght S, Willems P, Colle I, Van Hoof M, Van Acker J, Van Steenkiste C, Moreno C, Janssens F, Reynders M, Steverlynck M, Verlinden W, Lasser L, de Galocsy C, Geerts A, Maus J, Gallant M, Van Outryve S, Marot A, Reynaert H, Decaestecker J, Bottieau E, Schreiber J, Mulkay JP, de Goeij S, Salame M, Dooremont D, Dastis SN, Boes J, Nijs J, Beyls J, Hens N, Nevens F, Van Gucht S, Vanwolleghem T; Belgian Association for the Study of the Liver. Viral clade is associated with severity of symptomatic genotype 3 hepatitis E virus infections in Belgium, 2010-2018. J Hepatol. 2023 Jan;78(1):67-77. doi: 10.1016/j.jhep.2022.08.033. Epub 2022 Sep 6.

    PMID: 36075495DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples samples on which HEV serology (IgM and IgG), PCR and genotyping have been performed FFPE liver biopsy tissue blocks

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Thomas Vanwolleghem, MD PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 17, 2020

Study Start

January 1, 2010

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share