Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure

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. Identifier: NCT01481649
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
The University of Hong Kong

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).

Condition or disease
Exposure to Hepatitis B Virus

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 69 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

HBsAg-negative, anti-HBc-positive
HBsAg-negative, anti-HBc-positive subjects undergoing hematopoietic stem cell transplantation (HSCT)

Primary Outcome Measures :
  1. HBV reactivation (defined as detectable HBV DNA >20 IU/mL) [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for hematopoietic stem cell transplantation (HSCT) in Hong Kong

Inclusion Criteria:

  • Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
  • Documented anti-HBc (total)-positive.

Exclusion Criteria:

  • 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)

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 identifier (NCT number): NCT01481649

Hong Kong
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Wai-Kay Seto, MRCP The University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The University of Hong Kong Identifier: NCT01481649     History of Changes
Other Study ID Numbers: HKCTR-1422
HKCTR-1422 ( Registry Identifier: HKU CTC )
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by The University of Hong Kong:
hepatitis B

Additional relevant MeSH terms:
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