HepatitisNCT05062967
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
An observational study of Hepatitis and Liver Diseases, run by Maimónides Biomedical Research Institute of Córdoba at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Liver Diseases, Acute Hepatitis
- How many people
- 3,257 participants
- Where
- 10 sitesSpain
- Study dates
- 1 Jan 2022to 1 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.
- HAOD cohort (Cohort of patients with acute hepatitis of unknown origin)
- Patients older than 18 years with acute hepatitis of unknown origin (HAOD)
- OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients):
- Kidney or liver transplant subjects
- Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS))
- HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)
- TrazHE Cohort (Traceability cohort of Hepatitis E infections)
- Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
- Ortho-C-Rodent Collection:
- Wild and peri-urban rodents (rats) from different areas of Spain
- Ortho-C-Domestic Rodent Collection:
- Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Instituto de Investigacion En Recursos Cinegeticos (Irec)
Ciudad Real
JOSE FRANCISCO RUIZ FONS
JOSE FRANCISCO RUIZ FONS
Facultad de Veterinaria de Cordoba
Córdoba, 14004
DAVID CANO TERRIZA
DAVID CANO TERRIZA
Fundacion Investigacion Biomedica de Cordoba (Fibico)
Córdoba, 14004
ANTONIO RIVERO ROMAN
ANGELA CAMACHO ESPEJO
Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)
Córdoba, 14004
Hospital Universitario San Cecilio
Granada
ANA FUENTES LOPEZ
ANA FUENTES LOPEZ
Hospital de Jerez de La Frontera
Jerez de la Frontera, Cádiz
JUAN CARLOS ALADOS ARBOLEDAS
JUAN CARLOS ALADOS ARBOLEDAS
Clinica Universidad de Navarra
Madrid
GABRIEL REINA GONZALEZ
GABRIEL REINA GONZALEZ
Complejo Hospitalario de Especialidades Virgen de La Victoria
Málaga
ISABEL VICIANA RAMOS
ISABEL VICIANA RAMOS
Hospital de Puerto Real
Puerto Real, Cádiz, 11510
CAROLINA FREYRE CARRILLO
CAROLINA FREYRE CARRILLO
Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela
Santiago de Compostela, Galicia
ANTONIO AGUILERA GUIRAO
ANTONIO AGUILERA GUIRAO
About this study
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.
Read the detailed description
To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.
Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin
Secondary objectives are:
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
- To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
- To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
- To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
- To evaluate the prevalence of infection by Ortho-C in wild carnivores
- To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals
- Keywords
- Orthohepevirus C, Hepatitis, Liver Diseases
- Medical subject headings
- Hepatitis, Liver Diseases, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Yearly, up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,257 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANTONIO RIVERO ROMÁN, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062967
- Sponsor's protocol ID
- PI21/00793
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing the results of this study after they are made public.
Publications
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.
PubMed 40020930
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
- ClinicalTrials.gov ID
- NCT05062967
- Acronym / sponsor ID
- PI21/00793
- Keywords
- Orthohepevirus C, Hepatitis, Liver Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,257 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To carry out the project a database will be created in electronic format, where the study team will integrate epidemiological, clinical and laboratory tests data of patients. Data will be anonymous and coded by a data manager.
Primary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin
Secondary objectives are:
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.
- To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.
- To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
- To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.
- To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.
- To evaluate the prevalence of infection by Ortho-C in wild carnivores
- To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Existence of Ortho-C infection
Time frame: Yearly, up to three years.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 40020930Caballero-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.
- Individual participant dataSharing planned: Yes. Sharing the results of this study after they are made public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANTONIO RIVERO ROMÁN principal investigator
Hospital General Universitario Reina Sofía de Murcia
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis and Liver Diseases, run by Maimónides Biomedical Research Institute of Córdoba at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANTONIO RIVERO ROMÁN (957012421, ariveror@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Existence of Ortho-C infection (time frame: Yearly, up to three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05062967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.