Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease

Not Applicable

Terminated

• Conditions: Rheumatic Diseases; Ulcerative Colitis; Hepatitis B, Chronic; Crohn Disease; Inflammatory Bowel Disease
• Interventions: Other: HBV DNA level monitoring

• Registration Number: NCT02128503
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2015-10-16
• Study Completion: 2015-10-16
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-23
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• All IBD and rheumatologic patients aged 18 years or older

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HBV DNA level monitoring	HBV DNA level monitoring	Group with HBV DNV level being monitored regularly

Primary Outcome Measures

Name	Time	Method
Changes in HBV DNA levels	2 Years	Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong