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

NCT02799316 | Unknown DMC

• 1 other identifier: Rasha Abdelno
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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) .

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Number of patients with occult HBV.

  Number of patients having occult HBV.

  1 year

Study Arms (1)

rheumatic disease with HBs-ag positive

OTHER

• HBV core antibodies testing. • Real time PCR testing.

Other: HBV core antibodies testing. • Real time PCR testing.

Interventions

HBV core antibodies testing. • Real time PCR testing. OTHER

* HBV core antibodies testing in HBV surface antigen negative patients. * Real time PCR testing for those having positive HBc antibodies.

rheumatic disease with HBs-ag positive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Overt co-morbid condition.
• Any malignancy e.g. HCC

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Rasha A Abdel Noor, Consultant

  Internal medicine department - Tanta university

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Consultant

CONTACT

00201095159522; sherif_tropical@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant liver and GIT diseases- Tanta university hospital

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

EG (1)