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

NCT ID: NCT02799316

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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rheumatic disease with HBs-ag positive

• HBV core antibodies testing. • Real time PCR testing.

Group Type OTHER

HBV core antibodies testing. • Real time PCR testing.

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* • Overt co-morbid condition.

* Any malignancy e.g. HCC
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rasha A Abdel Noor, Consultant

Role: PRINCIPAL_INVESTIGATOR

Internal medicine department - Tanta university

Sherief Abd-Elsalam, Consultant

Role: STUDY_CHAIR

Division of Gastroenterology and Hepatology- Tanta

Walaa Elkhalawany, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Mona Watani, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Rehab Badawi, Consultant

Role: STUDY_CHAIR

liver diseases dept.-Tanta university hospital

Locations

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Sherief Abd-Elsalam

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, Consultant

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

00201000040794

Other Identifiers

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Rasha Abdelno

Identifier Type: -

Identifier Source: org_study_id

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