ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00881036
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Yoshihide Ueda, Kyoto University

Brief Summary:
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 or disease
Hepatitis B

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Activation of HBV Under Immunosuppression in HBsAg-negative But Anti-HBc-positive Patients With Hematological Malignancies
Study Start Date : August 2006
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00881036


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

Responsible Party: Yoshihide Ueda, Associate Professor, Kyoto University
ClinicalTrials.gov Identifier: NCT00881036     History of Changes
Other Study ID Numbers: HBV from anti-HBc positive
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015

Keywords provided by Yoshihide Ueda, 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