Back to resultsIs Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?
Primary Purpose
Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
HBV core antibodies testing. • Real time PCR testing.
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatitis B
Eligibility 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
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
rheumatic disease with HBs-ag positive
Arm Description
• HBV core antibodies testing. • Real time PCR testing.
Outcomes
Primary Outcome Measures
Number of patients with occult HBV.
Number of patients having occult HBV.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02799316
Brief Title
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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) .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rheumatic disease with HBs-ag positive
Arm Type
Other
Arm Description
• HBV core antibodies testing. • Real time PCR testing.
Intervention Type
Other
Intervention Name(s)
HBV core antibodies testing. • Real time PCR testing.
Intervention Description
HBV core antibodies testing in HBV surface antigen negative patients.
Real time PCR testing for those having positive HBc antibodies.
Primary Outcome Measure Information:
Title
Number of patients with occult HBV.
Description
Number of patients having occult HBV.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, Consultant
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasha A Abdel Noor, Consultant
Organizational Affiliation
Internal medicine department - Tanta university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Consultant
Organizational Affiliation
Division of Gastroenterology and Hepatology- Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Walaa Elkhalawany, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona Watani, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rehab Badawi, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?
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