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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihide Ueda, Kyoto University
ClinicalTrials.gov Identifier:
NCT00881036
First received: April 13, 2009
Last updated: September 2, 2015
Last verified: September 2015
  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:


Further study details as provided by Kyoto University:

Enrollment: 33
Study Start Date: August 2006
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00881036

Locations
Japan
Kyoto Univesity
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University
  More Information

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 2, 2015
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on December 05, 2016