Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease (NCT05062967) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Orthohepevirus C Infection as an Emerging Cause of Zoonotic Origin Disease
Spain3,257 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Existence of Ortho-C infection
Timeframe: Yearly, up to three years.
Trial details
NCT IDNCT05062967
SponsorMaimónides Biomedical Research Institute of Córdoba