Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease
Primary Purpose
Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis
Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
HBV DNA level monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- All IBD and rheumatologic patients aged 18 years or older
Exclusion Criteria:
- 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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HBV DNA level monitoring
Arm Description
Group with HBV DNV level being monitored regularly
Outcomes
Primary Outcome Measures
Changes in HBV DNA levels
Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants
Secondary Outcome Measures
Full Information
NCT ID
NCT02128503
First Posted
April 29, 2014
Last Updated
April 23, 2017
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02128503
Brief Title
Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease
Official Title
Prevalence and Clinical Course of Chronic Hepatitis B Infection in Patients With Inflammatory Bowel Disease and Rheumatologic Disease on Immunosuppressive Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
sample size recruited is not enough
Study Start Date
February 2013 (Actual)
Primary Completion Date
October 16, 2015 (Actual)
Study Completion Date
October 16, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The incidence of inflammatory bowel disease (IBD) has been increasing in Hong Kong. The management of inflammatory bowel disease involved the use of immunosuppressant, however, the use of immunosuppressant in patients with hepatitis B infection has been associated with hepatitis B reactivation. It is estimated that around 7% of the Hong Kong population is infected with HBV. The information on the prevalence of hepatitis B in IBD patients in Hong Kong is lacking. Moreover, limited information is available on the effect of different immunosuppressive regimens given for longer periods of time in lower doses in patients with chronic HBV infection and IBD. There is therefore a need to determine the incidence and predictive factors for HBV reactivation in these patients.
Rheumatologic diseases, including systemic lupus erythematous, rheumatoid arthritis, psoriasis and anklyosing spondylitis are inflammatory conditions which commonly affect the locomotors system as well as other organs. Epidemiological data from China have suggested that patients with ankylosing spondylitis have a higher risk of hepatitis B infection; while the rates of hepatitis B for those with rheumatoid arthritis, and other spondyloathropathies are similar to that of the general population. However, there are no such local data in Hong Kong aspect.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Rheumatic Diseases, Hepatitis B, Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBV DNA level monitoring
Arm Type
Other
Arm Description
Group with HBV DNV level being monitored regularly
Intervention Type
Other
Intervention Name(s)
HBV DNA level monitoring
Intervention Description
HBV DNV level being monitoring regularly
Primary Outcome Measure Information:
Title
Changes in HBV DNA levels
Description
Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All IBD and rheumatologic patients aged 18 years or older
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siew Chien Ng
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease
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