Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT02799316
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2016-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?
Sponsor:
Sherief Abd-Elsalam
Organization:
Study Overview
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??
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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) .
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: