Hepatitis BNCT01645007
Prevalence of Hepatitis B Infection in the Galilee Region, Israel
An observational study of Hepatitis B, run by Western Galilee Hospital-Nahariya.
Trial summary
Primary Aims: 1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee. 2. Educate the population in order to reduce transmission 3. Increase awareness among primary care providers Secondary Aims: 1. Identify chronic HBV infected patients who need to be followed and treated, 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Native Israeli Druze
Who may be able to join
- All consent adults who are 18 year old or older
Who cannot join
- Individuals younger than 18 year old
- Individuals who cannot or will not sign consent
About this study
Primary Aims:
- Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.
- Educate the population in order to reduce transmission
- Increase awareness among primary care providers
Read more
Secondary Aims:
- Identify chronic HBV infected patients who need to be followed and treated,
- Identify HBV infected women in a childbearing age
- Identify non immunized individuals and recommend vaccination
- Identify previously vaccinated individuals who are not immunized
- Identify previously vaccinated individuals who became infected
Study Design:
Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000 people from Druze communities in the Galilee area
This work will be divided into three sections:
- Increasing awareness: lectures and local events will be taken place in the communities. Written information will be given and primary care-providers mainly family doctors, nurses and obstetric surgeons will be involved.
- All participants, upon signing a consent will:
- Fill up a questioner
- Checked for weight, height and waist circumflex
- Have a blood sample taken
- Results and recommendations will be forwarded to all participants
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Prevalence, HBsAg, Vaccination, Galilee
- Medical subject headings
- Hepatitis B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
Why it stopped: The study was not carried out due to lack of funding and budget problems
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645007
- Sponsor's protocol ID
- 0025-12-NHR
- Status last verified
- Jun 2014
- First submitted
- 17 Jul 2012
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis B Infection in the Galilee Region, Israel
- ClinicalTrials.gov ID
- NCT01645007
- Acronym / sponsor ID
- 0025-12-NHR
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Prevalence, HBsAg, Vaccination, Galilee
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was not carried out due to lack of funding and budget problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- First posted
- 19 Jul 2012 (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.
Primary Aims:
- Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.
- Educate the population in order to reduce transmission
- Increase awareness among primary care providers
Secondary Aims:
- Identify chronic HBV infected patients who need to be followed and treated,
- Identify HBV infected women in a childbearing age
- Identify non immunized individuals and recommend vaccination
- Identify previously vaccinated individuals who are not immunized
- Identify previously vaccinated individuals who became infected
Study Design:
Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000 people from Druze communities in the Galilee area
This work will be divided into three sections:
- Increasing awareness: lectures and local events will be taken place in the communities. Written information will be given and primary care-providers mainly family doctors, nurses and obstetric surgeons will be involved.
- All participants, upon signing a consent will:
- Fill up a questioner
- Checked for weight, height and waist circumflex
- Have a blood sample taken
- Results and recommendations will be forwarded to all participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Native Israeli Druze
Key inclusion criteria (1 listed)
- All consent adults who are 18 year old or older
Key exclusion criteria (2 listed)
- Individuals younger than 18 year old
- Individuals who cannot or will not sign consent
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Western Galilee Hospital-Nahariya.
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: withdrawn, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 18 Jun 2014.