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

Ulcerative Colitis Clinical Trial

Official title:

Prevalence and Clinical Course of Chronic Hepatitis B Infection in Patients With Inflammatory Bowel Disease and Rheumatologic Disease on Immunosuppressive Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02128503
• Other study ID #: IBD-RA HBV
• Status: Terminated
• Phase: N/A
• First received: April 29, 2014
• Last updated: April 23, 2017
• Start date: February 2013
• Est. completion date: October 16, 2015

Study information

• Verified date: April 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 430
• Est. completion date: October 16, 2015
• Est. primary completion date: October 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Collagen Diseases
• Crohn Disease
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Rheumatic Diseases
• Ulcerative Colitis

Intervention

Other:
• HBV DNA level monitoring
HBV DNV level being monitoring regularly

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HBV DNA levels	Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants	2 Years