- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02749864
Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP) (PREVHEP)
Personalized Medicine in HCV Infection. A Prospective, Multicenter, Epidemiological Study to Evaluate the Prevalence of Hepatitis C Infection in Spain in 2015 (PREVHEP)
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Design of the study: Seroepidemiological and virological study of cross-sectional population-based.
Patients and sampling: The study population has been distributed in groups according to age (20-34; 35-49; 50-74 years) and sex. In order to select a representative sample of this overall population, three Spanish regions will be selected on the basis of their different HCV-related hospitalisation rates defined as follows: high, >120 cases/100,000 inhabitants (Madrid); medium, 90-119 cases/100,000 inhabitants (Cantabria); or low, <90 cases/100,000 inhabitants (Valencia).
The participants will be selected through a random, representative sample using our two-stage conglomerate sampling with stratification of the First-Stage Units. These FSUs are made up by the Basic Health Areas (Health Centers). The Second-Stage Units are made up by the individuals. The stratification criteria used in the first stage will be the socioeconomic status-rural/urban environment. The selection of sample elements will be carried out through simple random sampling from the healthcare card database pertaining to the selected Health Centers. A sequence of random, computer-generated numbers will be obtained.
Sample size: In order to achieve an accuracy of 0.4% in the estimate of a percentage through a two-tailed 95% confidence interval, assuming the prevalences indicated by age strata in the general Spanish population (0.6%, 1.9% and 2.7% respectively), a total of 12,263 subjects distributed as follows: 1,456 aged 20-34 years, 4,476 aged 35-49 years and 6,331 aged 50-74 years.
Anticipating an uptake of 9-15%,21 following invitation via telephone, between 81,753 and 136,255 subjects distributed over the three regions needed to be contacted at random.
Recruitment method for randomized patients. Selected subjects will be called by phone by trained personnel. The subject will be invited to report for an interview in order to carry out a socio-healthcare questionnaire, a physical examination, and an analytical test. In the event the patient refuses to participate, permission shall be requested to collect minimum anonymous data for the subsequent study of possible screening biases. Patients meeting inclusion criteria and provide written informed consent to be included in the study.
Variables in the study: socio-healthcare questionnaire includes variables such as age, sex, socioeconomic status, risk factors, health habits, etc. Analytical variables (blood count, biochemistry, serologies for HBV and HCV, etc.) are collected. A Fibroscan is also performed. A cost-effectiveness of screening strategies and treatment will be analysed using a Markov model
Full duration: 21 months
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Madrid, España, 28222
- Hospital Universitario Puerta de Hierro-Majadahonda
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Cantabria
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Santander, Cantabria, España, 39008
- Hospital Universitario Marqués de Valdecilla
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, España
- Hospital Clinico Universitario de Valencia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Do not meet the criteria above.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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A: Age 20-34 yr
No intervention Cohort of subjects aged 20-34 years old.
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B: Age 35-49 yr
No intervention Cohort of subjects aged 35-49 years old.
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C: Age 50-79 yr
No intervention Cohort of subjects aged 50-79 years old.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Serum Anti-HCV
Periodo de tiempo: 1 day
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Anti-HCV seroprevalence
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1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HCV RNA viral load
Periodo de tiempo: 1 day
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Chronic HCV infection
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1 day
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Serum HBsAg
Periodo de tiempo: 1 day
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HBV portador status
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1 day
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Birth date
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Sex
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
|
1 day
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Nationality
Periodo de tiempo: 1 day
|
Questionnaire about socio-economic and Health variables
|
1 day
|
Residence time in Spain
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
|
1 day
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Educational level
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Activity and professional qualifications
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Lifestyle habit/risk factor score
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Nosocomial risk score
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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History of previous check of HCV/HBV exposure
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
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1 day
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Sexual behaviour
Periodo de tiempo: 1 day
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Questionnarie about socio-economic and Health variables
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1 day
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Number of sexual partners
Periodo de tiempo: 1 day
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Questionnaire about socio-economic and Health variables
|
1 day
|
Weight (kg)
Periodo de tiempo: 1 day
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Weight (Anthropometric variables)
|
1 day
|
Height (cm)
Periodo de tiempo: 1 day
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Height (Anthropometric variables)
|
1 day
|
BMI
Periodo de tiempo: 1 day
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Body Mass Index (Anthropometric variables)
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1 day
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Abdominal perimeter (cm)
Periodo de tiempo: 1 day
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Abdominal perimeter (Anthropometric variables)
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1 day
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Waist perimeter (cm)
Periodo de tiempo: 1 day
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Waist perimeter (Anthropometric variables)
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1 day
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Blood pressure (mmHg)
Periodo de tiempo: 1 day
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Blood pressure
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1 day
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ALT
Periodo de tiempo: 1 day
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Liver function tests
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1 day
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AST
Periodo de tiempo: 1 day
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Liver function tests
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1 day
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Alkaline Phosphatase (AP)
Periodo de tiempo: 1 day
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Liver function tests
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1 day
|
GGT (Gammaglutamyl transferase)
Periodo de tiempo: 1 day
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Liver function tests
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1 day
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Bilirubin
Periodo de tiempo: 1 day
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Liver function tests
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1 day
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Serum Albumin
Periodo de tiempo: 1 day
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Biochemistry parameters
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1 day
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Total Cholesterol
Periodo de tiempo: 1 day
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Biochemistry parameters
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1 day
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LDL Cholesterol
Periodo de tiempo: 1 day
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Biochemistry parameters
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1 day
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HDL Cholesterol
Periodo de tiempo: 1 day
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Biochemistry parameters
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1 day
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Triglycerides
Periodo de tiempo: 1 day
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Biochemistry parameters
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1 day
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White blood cell count (WBC or leukocyte count)
Periodo de tiempo: 1 day
|
CBC
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1 day
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Hemoglobin
Periodo de tiempo: 1 day
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CBC
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1 day
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Platelets
Periodo de tiempo: 1 day
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CBC
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1 day
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INR
Periodo de tiempo: 1 day
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International Normalized Ratio
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1 day
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kPa in Fibroscan
Periodo de tiempo: 1 day
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Liver stiffness
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Javier Crespo García, MDPhD, Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
- Investigador principal: Jose L Calleja, MDPhD, Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
- Investigador principal: Miguel A Serra, MDPhD, Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones por Hepadnaviridae
- Infecciones por virus de ADN
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis C
Otros números de identificación del estudio
- JCG-PREVHEP-2015-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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