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Trial record 108 of 517 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University Identifier:
First received: June 10, 2016
Last updated: NA
Last verified: June 2016
History: No changes posted

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) .

Condition Intervention
Hepatitis B
Other: HBV core antibodies testing. • Real time PCR testing.

Study Type: Interventional
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??

Resource links provided by NLM:

Further study details as provided by Tanta University:

Primary Outcome Measures:
  • Number of patients with occult HBV. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • • Overt co-morbid condition.

    • Any malignancy e.g. HCC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02799316

Contact: Sherief Abd-Elsalam, Consultant 00201095159522

Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794   
Sponsors and Collaborators
Sherief Abd-Elsalam
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
  More Information

Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University Identifier: NCT02799316     History of Changes
Other Study ID Numbers: Rasha Abdelno 
Study First Received: June 10, 2016
Last Updated: June 10, 2016
Health Authority: Egypt: Ministry of Higher Education
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016