Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study

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 rituximab-containing chemotherapy.

Completed

Looking for future studies?

Notify Me

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 patients undergoing rituximab-containing chemotherapy 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 70 such patients 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 with or without antibody to 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

HBV reactivation (defined as detectable HBV DNA > 20 IU/mL)

Time frame: 2 years

From date of rituximab commencement up to 2 years

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: Dec 30, 2011
Registry last updated: Oct 1, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed