Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease

NCT05062967 | Unknown

• 1 other identifier: PI21/00793
• Study Type: observational
• Target: 3,257
• Locations: 1 country
• Sites: 10

Brief Summary

The main objective of this study is to evaluate the prevalence and the clinical impact of Orthohepevirus C infection in different human populations, and to determine its zoonotic origin comparing the sequences obtained in both human and animal populations. This is an ambispective study where Orthohepevirus C infection will be evaluated in four high risk human population: i) patients with acute hepatitis, ii) patients with positive IgM antibody against Hepatitis E virus infection with undetectable viral load, iii) HIV infected individuals, and iv) solid organ transplant recipients. Furthermore, we will analyze three animal populations: i) suburban rodents, ii) domestic rodents, iii) wild carnivores. Viral sequences identified in both human and animal populations will be compared to evaluate the zoonotic origin of the infections.

Conditions

Hepatitis; Liver Diseases; Acute Hepatitis; Chronic Hepatitis; Liver Disease Chronic

Keywords

Orthohepevirus C; Hepatitis; Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Existence of Ortho-C infection

  The presence of Ortho-C infection is defined by: * HAOD, TrazHE, OrthoC-Tx and Ortho-CoRIS cohorts: presence of RNA-OrthoC in blood. * Ortho-C-Rodent and Ortho-C-Carnivore cohorts: presence of RNA-OrthoC in serum, feces and/or liver tissue * Ortho-C-Domestic-Rodent cohort: presence of RNA-OrthoC in feces.

  Yearly, up to three years.

Study Arms (7)

HAOD Cohort

This cohort includes patients with acute hepatitis of unknown origin, meaning its origin could not be determined after screening of (at least) HAV, HAB, HAC, HAE, Epstein-Barr virus and cytomegalovirus. Patients will be recruited in 17 centres nationwide. The research group will receive a 1mL plasma / serum sample from each patient to study the presence of Ortho-C infection

OrthoC-Tx Cohort

This cohort includes liver or kidney transplant patients under follow-up. The research group will receive a 1mL plasma / serum sample every year from each patient to study the presence of Ortho-C infection

Ortho-CoRIS Cohort

This cohort includes VIH positive patients who are in follow-up by the Spanish Network of AIDS Research. The research group will receive a plasma / serum sample every year from each patient to study the presence of Ortho-C infection.

TrazHE Cohort

This cohort includes patients whose clinical picture is compatible with HAE infection. The presence of Ortho-C infection will be studied in patients with positive IgM for HAE and absence of RNA-HAE.

Ortho-C-Rodent Cohort

This cohort includes wild rats. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in wild rats (Ortho-C's main reservoir).

Ortho-C-Domestic Rodent Cohort

This cohort includes domestic rats and mustelids. Feces and liver samples will be taken in order to determine the prevalence of Ortho-C in domestic rats and mustelids.

Ortho-C-Carnivore Cohort

This cohort includes 236 wild carnivores that feed off rodents. Carnivores' cause of death is they were run over. Feces, liver and serum samples will be taken to study the transmission of Ortho-C.

Eligibility Criteria

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

Study Population

Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.

1\. HAOD cohort (Cohort of patients with acute hepatitis of unknown origin) * Patients older than 18 years with acute hepatitis of unknown origin (HAOD) 2\. OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients): * Kidney or liver transplant subjects 3\. Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS)) * HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS) 4\. TrazHE Cohort (Traceability cohort of Hepatitis E infections) * Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA 5\. Ortho-C-Rodent Collection: * Wild and peri-urban rodents (rats) from different areas of Spain 6\. Ortho-C-Domestic Rodent Collection: * Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities. 7\. Ortho-C-Carnivore Collection: * Wild carnivores that eat rodents collected by the research team since 2020 in 4 autonomous communities (Extremadura, Andalusia, Murcia and Castilla la Mancha)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (10)

Hospital de Jerez de La Frontera

Jerez de la Frontera, Cádiz, Spain

Location

Hospital de Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Location

Instituto de Investigacion En Recursos Cinegeticos (Irec)

Ciudad Real, Spain

Location

Facultad de Veterinaria de Cordoba

Córdoba, 14004, Spain

Location

Fundacion Investigacion Biomedica de Cordoba (Fibico)

Córdoba, 14004, Spain

Location

Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, Spain

Location

Clinica Universidad de Navarra

Madrid, Spain

Location

Complejo Hospitalario de Especialidades Virgen de La Victoria

Málaga, Spain

Location

Related Publications (1)

• Caballero-Gomez J, Casares-Jimenez M, Gallo-Marin M, Pereira-Pardo S, Beato-Benitez A, Poyato A, Guerra R, Avellon A, Schilling-Loeffler K, Freyre-Carrillo C, Garcia-Bocanegra I, Jimenez-Martin D, Corona-Mata D, Viciana I, Fajardo T, Munoz-Chimeno M, Quevedo MA, Rios-Munoz L, Perez AB, Cano-Terriza D, Macias J, Fuentes A, Johne R, Rivero-Juarez A, Rivero A; GEHEP-014 Study Group. Rat hepatitis E virus as an aetiological agent of acute hepatitis of unknown origin. J Hepatol. 2025 Sep;83(3):662-669. doi: 10.1016/j.jhep.2025.02.027. Epub 2025 Feb 26.

  PMID: 40020930 DERIVED

MeSH Terms

Conditions

Hepatitis; Liver Diseases; Hepatitis, Chronic

Condition Hierarchy (Ancestors)

Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ANTONIO RIVERO ROMÁN

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANTONIO RIVERO ROMÁN

CONTACT

957012421; ariveror@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 30, 2021
• Study Start: January 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After study results are published.
• Access Criteria: Send access request to principal investigator.

Locations

ES (10)