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

Hepatitis B Clinical Trial

Official title:

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??

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02799316
• Other study ID #: Rasha Abdelno
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 17, 2017
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• • Overt co-morbid condition.

• Any malignancy e.g. HCC

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sherief Abd-Elsalam	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with occult HBV.	Number of patients having occult HBV.	1 year