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

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ClinicalTrials.gov Identifier: NCT02128503
Recruitment Status : Terminated (sample size recruited is not enough)
First Posted : May 1, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis Rheumatic Diseases Hepatitis B, Chronic Other: HBV DNA level monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevalence and Clinical Course of Chronic Hepatitis B Infection in Patients With Inflammatory Bowel Disease and Rheumatologic Disease on Immunosuppressive Therapy
Actual Study Start Date : February 2013
Actual Primary Completion Date : October 16, 2015
Actual Study Completion Date : October 16, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Arm Intervention/treatment
HBV DNA level monitoring
Group with HBV DNV level being monitored regularly
Other: HBV DNA level monitoring
HBV DNV level being monitoring regularly




Primary Outcome Measures :
  1. Changes in HBV DNA levels [ Time Frame: 2 Years ]
    Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128503


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Chien Ng Chinese University of Hong Kong

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02128503     History of Changes
Other Study ID Numbers: IBD-RA HBV
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hepatitis
Hepatitis B
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Rheumatic Diseases
Collagen Diseases
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Gastroenteritis
Gastrointestinal Diseases
Colitis
Colonic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Hepatitis, Chronic