Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure
1 other identifier
observational
69
1 country
1
Brief Summary
The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
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
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 24, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 14, 2016
April 1, 2016
3.3 years
November 24, 2011
April 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBV reactivation (defined as detectable HBV DNA >20 IU/mL)
From date of hematopoietic stem cell transplantation (HSCT) to 2 years after HSCT.
2 years
Study Arms (1)
HBsAg-negative, anti-HBc-positive
HBsAg-negative, anti-HBc-positive subjects undergoing hematopoietic stem cell transplantation (HSCT)
Eligibility Criteria
Patients referred for hematopoietic stem cell transplantation (HSCT) in Hong Kong
You may qualify if:
- Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
- Documented anti-HBc (total)-positive.
You may not qualify if:
- Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
- Significant alcohol intake (\>30 grams per day)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Related Publications (1)
Seto WK, Chan TS, Hwang YY, Wong DK, Fung J, Liu KS, Gill H, Lam YF, Lau EHY, Cheung KS, Lie AKW, Lai CL, Kwong YL, Yuen MF. Hepatitis B reactivation in occult viral carriers undergoing hematopoietic stem cell transplantation: A prospective study. Hepatology. 2017 May;65(5):1451-1461. doi: 10.1002/hep.29022. Epub 2017 Mar 22.
PMID: 28027590DERIVED
Biospecimen
Serum and plasma for hepatitis B virus genotypic, virologic and serologic testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wai-Kay Seto, MRCP
The University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2011
First Posted
November 29, 2011
Study Start
November 1, 2011
Primary Completion
February 1, 2015
Study Completion
February 1, 2016
Last Updated
April 14, 2016
Record last verified: 2016-04