An observational study in Hepatitis, Liver Diseases and Acute Hepatitis, sponsored by Maimónides Biomedical Research Institute of Córdoba. Status unknown at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Observational
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.
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:
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 3,257 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Depending on the cohort. Please see "Group and Interventions" section to learn about the study population in each cohort.
Patients older than 18 years with acute hepatitis of unknown origin (HAOD)
Kidney or liver transplant subjects
HIV-infected patients being monitored by the Spanish AIDS Research Network (RIS)
Patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA
Wild and peri-urban rodents (rats) from different areas of Spain
Domestic rodents and mustelids under follow-up in veterinary clinics of different Spanish municipalities.
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
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
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.
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.
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).
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.
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.
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.
Time frame: Yearly, up to three years.
Plan to share: Yes — Sharing the results of this study after they are made public.
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba