Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure
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).
Exposure to Hepatitis B Virus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Risk of Hepatitis B Reactivation After Hematopoietic Stem Cell Transplantation in Donors and Recipients With Prior HBV Exposure|
- HBV reactivation (defined as detectable HBV DNA >20 IU/mL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]From date of hematopoietic stem cell transplantation (HSCT) to 2 years after HSCT.
Biospecimen Retention: Samples Without DNA
Serum and plasma for hepatitis B virus genotypic, virologic and serologic testing
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
HBsAg-negative, anti-HBc-positive subjects undergoing hematopoietic stem cell transplantation (HSCT)
Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481649
|Department of Medicine, The University of Hong Kong, Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Wai-Kay Seto, MRCP||The University of Hong Kong|