Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05062967
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2021-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3257}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Existence of Ortho-C infection', 'timeFrame': 'Yearly, up to three years.', 'description': 'The presence of Ortho-C infection is defined by:\n\n* HAOD, TrazHE, OrthoC-Tx and Ortho-CoRIS cohorts: presence of RNA-OrthoC in blood.\n* Ortho-C-Rodent and Ortho-C-Carnivore cohorts: presence of RNA-OrthoC in serum, feces and/or liver tissue\n* Ortho-C-Domestic-Rodent cohort: presence of RNA-OrthoC in feces.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthohepevirus C', 'Hepatitis', 'Liver Diseases'], 'conditions': ['Hepatitis', 'Liver Diseases', 'Acute Hepatitis', 'Chronic Hepatitis', 'Liver Disease Chronic']}, 'referencesModule': {'references': [{'pmid': '40020930', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPrimary objective is to assess the prevalence of Ortho-C infection in patients with acute hepatitis of no identified origin\n\nSecondary objectives are:\n\n1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.\n2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.\n3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA\n4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.\n5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.\n6. To evaluate the prevalence of infection by Ortho-C in wild carnivores\n7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': '1\\. HAOD cohort (Cohort of patients with acute hepatitis of unknown origin)\n\n* Patients older than 18 years with acute hepatitis of unknown origin (HAOD)\n\n 2\\. OrthoC-Tx cohort (HEV Screening Cohort in Transplant Patients):\n* Kidney or liver transplant subjects\n\n 3\\. Ortho-CoRIS Cohort (derived from the AIDS Research Network Cohort (CoRIS))\n* HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)\n\n 4\\. TrazHE Cohort (Traceability cohort of Hepatitis E infections)\n* Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA\n\n 5\\. Ortho-C-Rodent Collection:\n* Wild and peri-urban rodents (rats) from different areas of Spain\n\n 6\\. Ortho-C-Domestic Rodent Collection:\n* Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.\n\n 7\\. Ortho-C-Carnivore Collection:\n* Wild carnivores that eat rodents collected by the research team since 2020 in 4 autonomous communities (Extremadura, Andalusia, Murcia and Castilla la Mancha)'}, 'identificationModule': {'nctId': 'NCT05062967', 'briefTitle': 'Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease', 'orgStudyIdInfo': {'id': 'PI21/00793'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAOD Cohort', 'description': '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.\n\nThe research group will receive a 1mL plasma / serum sample from each patient to study the presence of Ortho-C infection'}, {'label': 'OrthoC-Tx Cohort', 'description': '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'}, {'label': 'Ortho-CoRIS Cohort', 'description': 'This cohort includes VIH positive patients who are in follow-up by the Spanish Network of AIDS Research.\n\nThe research group will receive a plasma / serum sample every year from each patient to study the presence of Ortho-C infection.'}, {'label': 'TrazHE Cohort', 'description': 'This cohort includes patients whose clinical picture is compatible with HAE infection.\n\nThe presence of Ortho-C infection will be studied in patients with positive IgM for HAE and absence of RNA-HAE.'}, {'label': 'Ortho-C-Rodent Cohort', 'description': "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)."}, {'label': 'Ortho-C-Domestic Rodent Cohort', 'description': '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.'}, {'label': 'Ortho-C-Carnivore Cohort', 'description': "This cohort includes 236 wild carnivores that feed off rodents. Carnivores' cause of death is they were run over.\n\nFeces, liver and serum samples will be taken to study the transmission of Ortho-C."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'contacts': [{'name': 'JUAN CARLOS ALADOS ARBOLEDAS', 'role': 'CONTACT'}, {'name': 'JUAN CARLOS ALADOS ARBOLEDAS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Jerez de La Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '11510', 'city': 'Puerto Real', 'state': 'Cádiz', 'country': 'Spain', 'contacts': [{'name': 'CAROLINA FREYRE CARRILLO', 'role': 'CONTACT'}, {'name': 'CAROLINA FREYRE CARRILLO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}, {'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'contacts': [{'name': 'ANTONIO AGUILERA GUIRAO', 'role': 'CONTACT'}, {'name': 'ANTONIO AGUILERA GUIRAO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Ciudad Real', 'country': 'Spain', 'contacts': [{'name': 'JOSE FRANCISCO RUIZ FONS', 'role': 'CONTACT'}, {'name': 'JOSE FRANCISCO RUIZ FONS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'RAUL CUADRADO MATIAS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto de Investigacion En Recursos Cinegeticos (Irec)', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'DAVID CANO TERRIZA', 'role': 'CONTACT'}, {'name': 'DAVID CANO TERRIZA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Facultad de Veterinaria de Cordoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'ANTONIO RIVERO ROMAN', 'role': 'CONTACT'}, {'name': 'ANGELA CAMACHO ESPEJO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ANTONIO RIVERO ROMAN', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ISABEL MARIA MACHUCA SANCHEZ', 'role': 'SUB_INVESTIGATOR'}, {'name': 'ANA BELEN PEREZ JIMENEZ', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fundacion Investigacion Biomedica de Cordoba (Fibico)', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'country': 'Spain', 'contacts': [{'name': 'ANA FUENTES LOPEZ', 'role': 'CONTACT'}, {'name': 'ANA FUENTES LOPEZ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'GABRIEL REINA GONZALEZ', 'role': 'CONTACT'}, {'name': 'GABRIEL REINA GONZALEZ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'contacts': [{'name': 'ISABEL VICIANA RAMOS', 'role': 'CONTACT'}, {'name': 'ISABEL VICIANA RAMOS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complejo Hospitalario de Especialidades Virgen de La Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'centralContacts': [{'name': 'ANTONIO RIVERO ROMÁN', 'role': 'CONTACT', 'email': 'ariveror@gmail.com', 'phone': '957012421'}], 'overallOfficials': [{'name': 'ANTONIO RIVERO ROMÁN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Reina Sofía'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After study results are published.', 'ipdSharing': 'YES', 'description': 'Sharing the results of this study after they are made public.', 'accessCriteria': 'Send access request to principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}