NCT02128503

Brief Summary

This study aims to determine the prevalence of HBV infection in patients with IBD and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2015

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

April 29, 2014

Last Update Submit

April 23, 2017

Conditions

Inflammatory Bowel DiseaseCrohn DiseaseUlcerative ColitisRheumatic DiseasesHepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

  • Changes in HBV DNA levels

    Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants

    2 Years

Study Arms (1)

HBV DNA level monitoring

OTHER

Group with HBV DNV level being monitored regularly

Other: HBV DNA level monitoring

Interventions

HBV DNA level monitoringOTHER

HBV DNV level being monitoring regularly

HBV DNA level monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All IBD and rheumatologic patients aged 18 years or older

You may not qualify if:

  • Lack of consent
  • Patients with evidence of other chronic liver disease,metabolic syndrome, men consuming more than 30 g of alcohol per day and women consuming more than 20 g of alcohol per day, patients with liver decompensation, HCC, previous liver surgery or liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativeRheumatic DiseasesHepatitis B, Chronic

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Siew Chien Ng

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

February 1, 2013

Primary Completion

October 16, 2015

Study Completion

October 16, 2015

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)