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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01502397

Enrollment

Registered

2011-12-30

Start date

2011-12-31

Completion date

2016-03-31

Last updated

2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure to Hepatitis B Virus

Keywords

hepatitis B, anti-HBc, HBsAg, rituximab, occult HBV

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 rituximab-containing chemotherapy.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
HBV reactivation (defined as detectable HBV DNA > 20 IU/mL)	2 years	From date of rituximab commencement up to 2 years

Countries

Hong Kong

Outcome results