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

June 17, 2017 updated by: Sherief Abd-Elsalam

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??

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) .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: rheumatic disease with HBs-ag positive
• HBV core antibodies testing. • Real time PCR testing.
Other: HBV 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with occult HBV.
Time Frame: 1 year
Number of patients having occult HBV.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Study Chair: Sherief Abd-Elsalam, Consultant, Division of Gastroenterology and Hepatology- Tanta
  • Principal Investigator: Rasha A Abdel Noor, Consultant, Internal medicine department - Tanta university
  • Study Chair: Walaa Elkhalawany, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Mona Watani, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Rehab Badawi, Consultant, liver diseases dept.-Tanta university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rasha Abdelno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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