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Completed

NCT Number: NCT01481649

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).

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Key information

Conditions

Exposure to Hepatitis B Virus Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Risk of Hepatitis B Reactivation After Hematopoietic Stem Cell Transplantation in Donors and Recipients With Prior HBV Exposure

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 29, 2011
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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