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

Hepatitis B Clinical Trial

Official title:

Activation of HBV Under Immunosuppression in HBsAg-negative But Anti-HBc-positive Patients With Hematological Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881036
• Other study ID #: HBV from anti-HBc positive
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: September 2, 2015
• Start date: August 2006
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HBsAg-negative but anti-HBc-positive

Exclusion Criteria:

• Serum HBV DNA-negative

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Japan	Kyoto Univesity	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan,