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

Not Applicable

• Conditions: Hepatitis B
• Interventions: Other: HBV core antibodies testing. • Real time PCR testing.

• Registration Number: NCT02799316
• Lead Sponsor: Sherief Abd-Elsalam

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-14
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-17
• Last Update Posted: 2017-06-20
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• • Overt co-morbid condition.

  • Any malignancy e.g. HCC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rheumatic disease with HBs-ag positive	HBV core antibodies testing. • Real time PCR testing.	• HBV core antibodies testing. • Real time PCR testing.

Primary Outcome Measures

Name	Time	Method
Number of patients with occult HBV.	1 year	Number of patients having occult HBV.

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Cairo, Egypt