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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05062967
• Other study ID #: PI21/00793
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: ANTONIO RIVERO ROMÁN
• Phone: 957012421
• Email: ariveror[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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:

1. To evaluate the prevalence and risk factors of Ortho-C infection in patients with solid organ transplant.

2. To evaluate the prevalence and risk factors of Ortho-C infection in patients with HIV infection.

3. To assess the presence of Ortho-C infection in patients with the presence of antibodies (IgM) against HEV and absence of HEV-RNA

4. To evaluate the prevalence of infection by Ortho-C in wild and periurban rodents.

5. To evaluate the prevalence of infection by Ortho-C in domestic rodents and mustelids.

6. To evaluate the prevalence of infection by Ortho-C in wild carnivores

7. To molecularly characterize and evaluate the degree of homology of Ortho-C viral sequences found in humans and animals

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3257
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Hepatitis
• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Liver Disease Chronic
• Liver Diseases

Locations

Country	Name	City	State
Spain	Instituto de Investigacion En Recursos Cinegeticos (Irec)	Ciudad Real
Spain	Facultad de Veterinaria de Cordoba	Córdoba
Spain	Fundacion Investigacion Biomedica de Cordoba (Fibico)	Córdoba
Spain	Instituto Maimonides de Investigacion Biomedica de Cordoba (Imibic)	Córdoba
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital de Jerez de La Frontera	Jerez De La Frontera	Cádiz
Spain	Clinica Universidad de Navarra	Madrid
Spain	Complejo Hospitalario de Especialidades Virgen de La Victoria	Málaga
Spain	Hospital de Puerto Real	Puerto Real	Cádiz
Spain	Fundacion Instituto de Investigacion Sanitaria de Santiago de Compostela	Santiago De Compostela	Galicia

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.