Hepatitis CPREVHEPNCT02749864
Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP)
An observational study of Hepatitis C and Hepatitis B, run by Instituto de Investigación Marqués de Valdecilla at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Hepatitis C, Hepatitis B
- How many people
- 12,246 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jul 2015to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Do not meet the criteria above.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, 28222
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Universitario de Valencia
Valencia, Valencia
About this study
Official title: 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
Read the detailed description
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
- Conditions
- Hepatitis C, Hepatitis B
- Keywords
- Hepatitis, Prevalence, Epidemiology, Infectious diseases
- Medical subject headings
- Hepatitis C, Hepatitis B, Hepatitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Anti-HCV
Anti-HCV seroprevalence
Measured: 1 day
Secondary outcomes (34)
HCV RNA viral load
Chronic HCV infection
Measured: 1 day
Serum HBsAg
HBV portador status
Measured: 1 day
Birth date
Questionnaire about socio-economic and Health variables
Measured: 1 day
Sex
Questionnaire about socio-economic and Health variables
Measured: 1 day
Nationality
Questionnaire about socio-economic and Health variables
Measured: 1 day
Residence time in Spain
Questionnaire about socio-economic and Health variables
Measured: 1 day
Educational level
Questionnaire about socio-economic and Health variables
Measured: 1 day
Activity and professional qualifications
Questionnaire about socio-economic and Health variables
Measured: 1 day
Lifestyle habit/risk factor score
Questionnaire about socio-economic and Health variables
Measured: 1 day
Nosocomial risk score
Questionnaire about socio-economic and Health variables
Measured: 1 day
History of previous check of HCV/HBV exposure
Questionnaire about socio-economic and Health variables
Measured: 1 day
Sexual behaviour
Questionnarie about socio-economic and Health variables
Measured: 1 day
Number of sexual partners
Questionnaire about socio-economic and Health variables
Measured: 1 day
Weight (kg)
Weight (Anthropometric variables)
Measured: 1 day
Height (cm)
Height (Anthropometric variables)
Measured: 1 day
BMI
Body Mass Index (Anthropometric variables)
Measured: 1 day
Abdominal perimeter (cm)
Abdominal perimeter (Anthropometric variables)
Measured: 1 day
Waist perimeter (cm)
Waist perimeter (Anthropometric variables)
Measured: 1 day
Blood pressure (mmHg)
Blood pressure
Measured: 1 day
ALT
Liver function tests
Measured: 1 day
AST
Liver function tests
Measured: 1 day
Alkaline Phosphatase (AP)
Liver function tests
Measured: 1 day
GGT (Gammaglutamyl transferase)
Liver function tests
Measured: 1 day
Bilirubin
Liver function tests
Measured: 1 day
Serum Albumin
Biochemistry parameters
Measured: 1 day
Total Cholesterol
Biochemistry parameters
Measured: 1 day
LDL Cholesterol
Biochemistry parameters
Measured: 1 day
HDL Cholesterol
Biochemistry parameters
Measured: 1 day
Triglycerides
Biochemistry parameters
Measured: 1 day
White blood cell count (WBC or leukocyte count)
CBC
Measured: 1 day
Hemoglobin
CBC
Measured: 1 day
Platelets
CBC
Measured: 1 day
INR
International Normalized Ratio
Measured: 1 day
kPa in Fibroscan
Liver stiffness
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start1 Jul 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Crespo García, MDPhD, Study director, Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de CantabriaJose L Calleja, MDPhD, Principal investigator, Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-MajadahondaMiguel A Serra, MDPhD, Principal investigator, Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749864
- Sponsor's protocol ID
- JCG-PREVHEP-2015-01
- Acronym
- PREVHEP
- Status last verified
- Sep 2018
- First submitted
- 16 Apr 2016
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
PubMed 16828003Ditah 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.
PubMed 24291324McGarry 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.
PubMed 22135116Ezcurra 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.
PubMed 38015591Llop 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.
PubMed 34077628
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine in HCV Infection. A Prospective, Multicenter, Epidemiological Study to Evaluate the Prevalence of Hepatitis C Infection in Spain in 2015 (PREVHEP)
- ClinicalTrials.gov ID
- NCT02749864
- Acronym / sponsor ID
- PREVHEP / JCG-PREVHEP-2015-01
- Conditions
- Hepatitis C, Hepatitis B
- Keywords
- Hepatitis, Prevalence, Epidemiology, Infectious diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,246 participants (actual)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Do not meet the criteria above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Anti-HCV
Time frame: 1 day
Anti-HCV seroprevalence
34 secondary outcomes
HCV RNA viral load
Time frame: 1 day
Serum HBsAg
Time frame: 1 day
Birth date
Time frame: 1 day
Sex
Time frame: 1 day
Nationality
Time frame: 1 day
Residence time in Spain
Time frame: 1 day
Educational level
Time frame: 1 day
Activity and professional qualifications
Time frame: 1 day
Lifestyle habit/risk factor score
Time frame: 1 day
Nosocomial risk score
Time frame: 1 day
History of previous check of HCV/HBV exposure
Time frame: 1 day
Sexual behaviour
Time frame: 1 day
Number of sexual partners
Time frame: 1 day
Weight (kg)
Time frame: 1 day
Height (cm)
Time frame: 1 day
BMI
Time frame: 1 day
Abdominal perimeter (cm)
Time frame: 1 day
Waist perimeter (cm)
Time frame: 1 day
Blood pressure (mmHg)
Time frame: 1 day
ALT
Time frame: 1 day
AST
Time frame: 1 day
Alkaline Phosphatase (AP)
Time frame: 1 day
GGT (Gammaglutamyl transferase)
Time frame: 1 day
Bilirubin
Time frame: 1 day
Serum Albumin
Time frame: 1 day
Total Cholesterol
Time frame: 1 day
LDL Cholesterol
Time frame: 1 day
HDL Cholesterol
Time frame: 1 day
Triglycerides
Time frame: 1 day
White blood cell count (WBC or leukocyte count)
Time frame: 1 day
Hemoglobin
Time frame: 1 day
Platelets
Time frame: 1 day
INR
Time frame: 1 day
kPa in Fibroscan
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Background: PubMed 16828003Bruguera M, Forns X. [Hepatitis C in Spain]. Med Clin (Barc). 2006 Jun 17;127(3):113-7. doi: 10.1157/13090276. Spanish.
- Background: PubMed 24291324Ditah 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.
- Background: PubMed 22135116McGarry 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.
- Derived from this study: PubMed 38015591Ezcurra 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.
- Derived from this study: PubMed 34077628Llop 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Crespo García, MDPhD study director
Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla. Professor at the Universidad de Cantabria
Jose L Calleja, MDPhD principal investigator
Head of Gastroenterology and Hepatology at Hospital Universitario Puerta de Hierro-Majadahonda
Miguel A Serra, MDPhD principal investigator
Gastroenterology and Hepatology Department at Hospital Clínico U. de Valencia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Hepatitis B, run by Instituto de Investigación Marqués de Valdecilla at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Anti-HCV (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749864, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.