NCT02324218

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161,429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

December 11, 2014

Last Update Submit

July 18, 2016

Conditions

Hepatitis B

Keywords

Diabetes mellitusHepatitis BIncidence

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Up to 12 years

Secondary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to 12 years

Study Arms (2)

Diabetes mellitus Group

All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.

Other: Data collection

Non-Diabetes mellitus Group

All the subjects with hepatitis B who are diagnosed negative diabetes mellitus, reported in the CPRD database of UK, from the Year 2000 to 2012.

Other: Data collection

Interventions

Data collectionOTHER

Data extraction from CPRD database of UK.

Diabetes mellitus GroupNon-Diabetes mellitus Group

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.

You may qualify if:

  • Subjects, 0 to 80 years of age during the study period.
  • Subjects acceptable for research as per CPRD definition:
  • Acceptable flag for research.
  • Particular Case of New Born Children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ferreira GLC, Marano C, De Moerlooze L, Guignard A, Feng Y, El Hahi Y, van Staa T. 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. 2018 May;25(5):571-580. doi: 10.1111/jvh.12841. Epub 2018 Jan 17.

    PMID: 29220868DERIVED

MeSH Terms

Conditions

Hepatitis BDiabetes Mellitus

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 24, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 19, 2016

Record last verified: 2016-07