Hepatitis BNCT02548325
Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study
An observational study of Hepatitis B, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Not apply
- How many people
- 1,001 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2014to Jul 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The are Included consecutively for one year ( 1 June 2014 to 31 May 2015 ) all patients who are in the inclusion criteria
Who may be able to join
- Patients with HBsAg + visited in Digestive/Hepatology outpatient visits and Hepatology of the participating hospitals
Who cannot join
- Patients < 18 aged
- Duplicity on record
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not.
Read the detailed description
The hepatitis B virus ( HBV ) is a global health problem . It is estimated that in the world there are about 350-400 million carriers of HBV surface antigen ( HBsAg ) 1 .
The prevalence in Spain is estimated at a 2-7 % and is considered a second intermediate prevalence.
For over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis B including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . For this reason , we want to evaluate what is the currently prevalence in our area of influence. There aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)
- Conditions
- Hepatitis B
- Being tested
- Not apply
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applyOther
None. Just registration epidemiology dates
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence hepatitis B
Measured: 12 months
Secondary outcomes (1)
stage of the disease and if they are in treatment or not
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 posted14 Sep 2015 (estimated)
- Study start1 Jun 2014
- Primary completion31 May 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, Mireia Miquel-Planas, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548325
- Sponsor's protocol ID
- CorporacionPT
- Status last verified
- Jan 2019
- First submitted
- 8 Sep 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis B in Vallés Occidental. Observational Multicentric Study
- ClinicalTrials.gov ID
- NCT02548325
- Acronym / sponsor ID
- CorporacionPT
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Consorci Sanitari de Terrassa
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 May 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Sep 2015 (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 aim of this study is to evaluate the prevalence of hepatitis B in Vallés Occidental. Also, describe the stage of the disease, and whether if they are under medical treatment or not.
Detailed description
The hepatitis B virus ( HBV ) is a global health problem . It is estimated that in the world there are about 350-400 million carriers of HBV surface antigen ( HBsAg ) 1 .
The prevalence in Spain is estimated at a 2-7 % and is considered a second intermediate prevalence.
For over 20 years, has carried out a program of primary prevention through universal vaccination against hepatitis B including it in the childhood vaccination schedule and has already been observed that in some estudi3 the prevalence has declined . For this reason , we want to evaluate what is the currently prevalence in our area of influence. There aren't recent studies to assess what is the current status of these patients ( how many , what risk factors which needs of treatment and with answer ...)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The are Included consecutively for one year ( 1 June 2014 to 31 May 2015 ) all patients who are in the inclusion criteria
Key inclusion criteria (1 listed)
- Patients with HBsAg + visited in Digestive/Hepatology outpatient visits and Hepatology of the participating hospitals
Key exclusion criteria (2 listed)
- Patients < 18 aged
- Duplicity on record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applyNone. Just registration epidemiology dates | Other | – |
Primary outcome
prevalence hepatitis B
Time frame: 12 months
1 secondary outcome
stage of the disease and if they are in treatment or not
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 1 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Corporacion Parc Tauli at 1 site 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 1 inclusion and 2 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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
prevalence hepatitis B (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.