HepatitisNCT01159951
Analysis of Trends Over Time of Hepatitis Related Incidence in Panama
An observational study of Hepatitis, run by GlaxoSmithKline at 1 site in Panama.
Trial summary
The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis
- What is being tested?
- Epidemiologic Surveillance System of the Ministry of Health of Panama
- How many people
- 1 participants
- Where
- 1 sitePanama
- Study dates
- Jan 2009to Aug 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.
Who may be able to join
- Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010
The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.
Read the detailed description
In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.
- Conditions
- Hepatitis
- Being tested
- Epidemiologic Surveillance System of the Ministry of Health of Panama
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiologic Surveillance System of the Ministry of Health of PanamaOther
Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis Cohort | Subjects suffering with hepatitis Receives: Other: Epidemiologic Surveillance System of the Ministry of Health of Panama |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)
Measured: In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)
Secondary outcomes (3)
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year
Measured: From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups
Measured: From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region
Measured: From year 2000 until year 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159951
- Sponsor's protocol ID
- 112263
- Status last verified
- Jun 2017
- First submitted
- 8 Jul 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
Publications
Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.
PubMed 25981490
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010
- ClinicalTrials.gov ID
- NCT01159951
- Acronym / sponsor ID
- 112263
- Conditions
- Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Jul 2010 (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 purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.
Detailed description
In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis Cohort | – | Other: Epidemiologic Surveillance System of the Ministry of Health of PanamaSubjects suffering with hepatitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.
Key inclusion criteria (1 listed)
- Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Epidemiologic Surveillance System of the Ministry of Health of PanamaSystematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama | Other | Hepatitis Cohort |
Primary outcome
Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)
Time frame: In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)
3 secondary outcomes
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year
Time frame: From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups
Time frame: From year 2000 until year 2010
Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region
Time frame: From year 2000 until year 2010
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 7 Jun 2017.
- Derived from this study: PubMed 25981490Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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, run by GlaxoSmithKline at 1 site in Panama.
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 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 7 Jun 2017. 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 Panama. 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?
Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) (time frame: In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)). 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 NCT01159951, which also lists 1 linked publication.
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 7 Jun 2017.