Last updated: 11/07/2018 12:10:27

This study aims to determine the incidence, of hepatitis B diagnosis among diabetes mellitus patients of 0-80 years of age

GSK study ID
201335
See study documents
Clinicaltrials.gov ID
NCT02324218
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Incidence of hepatitis B diagnosis among diabetes mellitus patients of 0-80 years of age, in the United Kingdom Clinical Practice Research Datalink (CPRD)
Trial description: This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).

Timeframe: Up to 12 years

Occurrence of new HepB diagnosis among non-DM patients between 0-80 years of age, in the UK CPRD or HES.

Timeframe: Up to 12 years

Secondary outcomes:

Hospitalisation episode recorded in HES due to HepB infection or complications among patients between 0-80 years of age previously diagnosed with DM and in DM-free (non-DM) patients, in the UK, for whom CPRD-HES linkage is available.

Timeframe: Up to 12 years

All cause mortality among HepB cases in the DM and DM-free (non-DM) patients between 0-80 years of age, in the UK.

Timeframe: Up to 12 years

HepB cause-specific mortality among DM and DM-free (non-DM) patients between 0-80 years of age, in the UK for whom CPRD-ONS mortality linkage is available.

Timeframe: Up to 12 years

New-onset or prevalent HepB diagnosis among new-onset or prevalent DM and DM-free (non-DM) patients between 0-80 years of age, in the UK, regardless of the onset of HepB in relation to the diagnosis of DM.

Timeframe: Up to 12 years

Interventions:
  • Other: Data collection
    • Enrollment:
    161429
    Primary completion date:
    2015-16-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Ferreira GLC et al. (2018) Incidence and prevalence of hepatitis B in patients with diabetes mellitus in the UK: A population-based cohort study using the UK Clinical Practice Research Datalink. J Viral Hepat. (5):571-580.
    Williams T et al. (2012) Recent advances in the utility and use of the General Practice Research Database as an example of a UK Primary Care Data resource. Therapeutic Advances in Drug Safety [Internet]. 3(2):89–99.
    Medical condition
    Hepatitis B
    Product
    SKF103860
    Collaborators
    Not applicable
    Study date(s)
    October 2014 to January 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    0 - 80 years
    Accepts healthy volunteers
    No
    • Subjects, 0 to 80 years of age during the study period.
    • Subjects acceptable for research as per CPRD definition:
    • For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects, 0 to 80 years of age during the study period.

      • Subjects acceptable for research as per CPRD definition:

      Acceptable flag for research.

      • Subjects with at least 12 months of observation time at the time of inclusion in the study:
    • Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.

      • Subjects have to be registered in a general practitioner practice classified as ‘up to standard’ for at least 12 months at the date of inclusion in the study.

      • Particular Case of New Born Children.

      To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.

      • Inclusion Date
    • Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.
    Exclusion criteria:

      For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-16-01
    Actual study completion date
    2015-16-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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