NCT02749864

Brief Summary

The hypothesis of this investigation stresses that the current understanding of the prevalence of HCV infection in the general population and in different subgroups will serve to lay out medium- and long-term measures for action geared toward reducing the disease burden through preventive, research, screening and therapeutic measures. Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to analyze the associated factors. To analyze and infer different screening strategies for HCV infection based on the at-risk groups/cohorts of elevated prevalence detected. to assess the efficiency of screening strategies and the subsequent cost-effectiveness of treatment in the general population

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

April 16, 2016

Last Update Submit

September 24, 2018

Conditions

Hepatitis CHepatitis B

Keywords

HepatitisPrevalenceEpidemiologyInfectious diseases

Outcome Measures

Primary Outcomes (1)

  • Serum Anti-HCV

    Anti-HCV seroprevalence

    1 day

Secondary Outcomes (34)

  • HCV RNA viral load

    1 day

  • Serum HBsAg

    1 day

  • Birth date

    1 day

  • Sex

    1 day

  • Nationality

    1 day

  • +29 more secondary outcomes

Study Arms (3)

A: Age 20-34 yr

No intervention Cohort of subjects aged 20-34 years old.

B: Age 35-49 yr

No intervention Cohort of subjects aged 35-49 years old.

C: Age 50-79 yr

No intervention Cohort of subjects aged 50-79 years old.

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population aged 20-74 years who agree to participate when contacted by phone call after a two-stage conglomerate sampling with stratification of the First-Stage Units. The study will be carried out in three Autonomous Communities (regions) in Spain.

You may qualify if:

  • Patients between 20 and 74 who have health card in each of the autonomous communities studied.
  • They agree to participate, understand and give informed consent.

You may not qualify if:

  • Do not meet the criteria above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, 28222, Spain

Location

Related Publications (5)

  • Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.

    PMID: 16828003BACKGROUND

  • Ditah I, Ditah F, Devaki P, Ewelukwa O, Ditah C, Njei B, Luma HN, Charlton M. The changing epidemiology of hepatitis C virus infection in the United States: National Health and Nutrition Examination Survey 2001 through 2010. J Hepatol. 2014 Apr;60(4):691-8. doi: 10.1016/j.jhep.2013.11.014. Epub 2013 Nov 27.

    PMID: 24291324BACKGROUND

  • McGarry LJ, Pawar VS, Panchmatia HR, Rubin JL, Davis GL, Younossi ZM, Capretta JC, O'Grady MJ, Weinstein MC. Economic model of a birth cohort screening program for hepatitis C virus. Hepatology. 2012 May;55(5):1344-55. doi: 10.1002/hep.25510. Epub 2012 Mar 18.

    PMID: 22135116BACKGROUND

  • Ezcurra I, Puente A, Cuadrado A, Tamayo I, Iruzubieta P, Arias-Loste MT, Gonzalez FJ, Pellon R, Sanchez S, Crespo J, Acebo M, Lopez-Hoyos M, Perez R, Cuesta A, Anton A, Echavarria V, Fabrega E, Crespo J, Fortea JI. No evidence of association between inherited thrombophilia and increased risk of liver fibrosis. United European Gastroenterol J. 2023 Dec;11(10):1010-1020. doi: 10.1002/ueg2.12500. Epub 2023 Nov 28.

    PMID: 38015591DERIVED

  • Llop E, Iruzubieta P, Perello C, Fernandez Carrillo C, Cabezas J, Escudero MD, Gonzalez M, Hernandez Conde M, Puchades L, Arias-Loste MT, Serra MA, Crespo J, Calleja JL. High liver stiffness values by transient elastography related to metabolic syndrome and harmful alcohol use in a large Spanish cohort. United European Gastroenterol J. 2021 Oct;9(8):892-902. doi: 10.1002/ueg2.12109. Epub 2021 Jun 2.

    PMID: 34077628DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples of whole blood, plasma and serum will be collected to analyse different markers related to the virus and the medical status of the patients. DNA samples will be transferred to the Biobank Valdecilla (Node DNA and fluids) according to Spanish law. Law 14/2007 of 3 July, on biomedical research and the Biobank law: Royal Decree 1716/2011, establishing the basic requirements for authorization and operation of biobanks are established for biomedical research and treatment of biological samples of human origin

MeSH Terms

Conditions

Hepatitis CHepatitis BHepatitisCommunicable Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Crespo García, MDPhD

    Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria

    STUDY DIRECTOR

  • Jose L Calleja, MDPhD

    Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda

    PRINCIPAL INVESTIGATOR

  • Miguel A Serra, MDPhD

    Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2016

First Posted

April 25, 2016

Study Start

July 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)