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Activation of Hepatitis B Virus (HBV) in Hepatitis B Surface Antigen (HBsAg) - Negative But Hepatitis B Core Antibody (Anti-HBc) - Positive Patients

This study is currently recruiting participants.
Verified September 2012 by Kyoto University
Sponsor:
Information provided by (Responsible Party):
Yoshihide Ueda, Kyoto University
ClinicalTrials.gov Identifier:
NCT00881036
First received: April 13, 2009
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

Individuals with resolved hepatitis B, characterized as hepatitis B surface antigen (HBsAg)-negative and hepatitis B core antibody-positive, have latent hepatitis B virus (HBV) infection in their liver tissue. Cytotoxic chemotherapy and hematopoietic stem cell transplantation sometimes trigger the reactivation of latently infected HBV, resulting in de novo hepatitis B. Although de novo hepatitis B could cause acute liver failure or chronic hepatitis, an effective management strategy for de novo hepatitis B has not been well established. Risk factors and effective management for de novo hepatitis B will be clarified.


Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Activation of HBV Under Immunosuppression in HBsAg-negative But Anti-HBc-positive Patients With Hematological Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University:

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HBsAg-negative but anti-HBc-positive patients with hematological malignancies treated at Kyoto University Hospital

Criteria

Inclusion Criteria:

  • HBsAg-negative but anti-HBc-positive

Exclusion Criteria:

  • Serum HBV DNA-negative
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881036

Locations
Japan
Kyoto Univesity Recruiting
Kyoto, Japan, 606-8507
Contact: Yoshihide Ueda, M.D. and Ph.D.     81-75-751-3111     yueda@kuhp.kyoto-u.ac.jp    
Principal Investigator: Yoshihide Ueda, M.D. and Ph.D.            
Sponsors and Collaborators
Kyoto University
  More Information

No publications provided

Responsible Party: Yoshihide Ueda, Associate Professor, Kyoto University
ClinicalTrials.gov Identifier: NCT00881036     History of Changes
Other Study ID Numbers: HBV from anti-HBc positive
Study First Received: April 13, 2009
Last Updated: September 25, 2012
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kyoto University:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hematologic Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Neoplasms by Site
Neoplasms
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013