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Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?

Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test for Hepatitis B Virus Infection in Rheumatic Disease Patients Before Starting Immunosuppressive Therapies??

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02799316
Enrollment
100
Registered
2016-06-14
Start date
2016-06-30
Completion date
2018-01-31
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

Hepatitis B virus (HBV) infection is a challenging health problem. According to the World Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV infection worldwide. After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface antigen (HBsAg) had generally been believed to signify viral elimination. However, it now becomes clear that those subjects may have occult HBV infection which is defined as the presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers (seronegative occult HBV infection) .

Detailed description

In a recent systematic review, nearly 40% of HBsAg carriers and 5% of antiHBc-positive but HBsAg-negative patients developed HBVr during TNF inhibitor therapy. Considering the lifelong use of multiple antirheumatic drugs, we need more specific guidelines for the management of rheumatic disease patients who are scheduled to receive biological and/or non-biological DMARDs.

Interventions

OTHERHBV core antibodies testing. • Real time PCR testing.

* HBV core antibodies testing in HBV surface antigen negative patients. * Real time PCR testing for those having positive HBc antibodies.

Sponsors

Sherief Abd-Elsalam
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* • Any patients with rheumatic disease with hepatitis B surface antigen negative.

Exclusion criteria

* • Overt co-morbid condition. * Any malignancy e.g. HCC

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with occult HBV.1 yearNumber of patients having occult HBV.

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, Consultant
sherif_tropical@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026