Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before 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 Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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??|
- Number of patients with occult HBV. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2016|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
rheumatic disease with HBs-ag positive
• HBV core antibodies testing. • Real time PCR testing.
Other: HBV core antibodies testing. • Real time PCR testing.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02799316
|Contact: Sherief Abd-Elsalam, Consultantfirstname.lastname@example.org|
|Contact: Sherief Abd-elsalam, lecturer 00201000040794 Sherif_tropical@yahoo.com|
|Principal Investigator:||Rasha A Abdel Noor, Consultant||Internal medicine department - Tanta university|
|Study Chair:||Sherief Abd-Elsalam, Consultant||Division of Gastroenterology and Hepatology- Tanta|
|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|