NCT00881036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

8.9 years

First QC Date

April 13, 2009

Last Update Submit

September 2, 2015

Conditions

Hepatitis B

Keywords

Hepatitis B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • HBsAg-negative but anti-HBc-positive

You may not qualify if:

  • Serum HBV DNA-negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto Univesity

Kyoto, Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

August 1, 2006

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

JP(1)