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Trial record 57 of 339 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02799316
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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) .


Condition or disease Intervention/treatment Phase
Hepatitis B Other: HBV core antibodies testing. • Real time PCR testing. Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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??
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of patients with occult HBV. [ Time Frame: 1 year ]
    Number of patients having occult HBV.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • • Overt co-morbid condition.

    • Any malignancy e.g. HCC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799316


Contacts
Contact: Sherief Abd-Elsalam, Consultant 00201095159522 sherif_tropical@yahoo.com

Locations
Egypt
Sherief Abd-Elsalam Recruiting
Cairo, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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

Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier: NCT02799316     History of Changes
Other Study ID Numbers: Rasha Abdelno
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis
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
Antibodies
Immunoglobulins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs