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CompletedNCT01502397Updated Oct 1, 2019

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

An observational study in Exposure to Hepatitis B Virus, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by The University of Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exposure to Hepatitis B Virus

Keywords

  • hepatitis B
  • anti-HBc
  • HBsAg
  • rituximab
  • occult HBV
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 70 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with B-cell lymphomas or chronic lymphocytic leukaemia referred to Queen Mary Hospital for rituximab-containing chemotherapy

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • HBsAg-negative, anti-HBc-positive

    HBsAg-negative, anti-HBc-positive subjects undergoing rituximab-containing chemotherapy

06

What researchers measure

Primary outcomes

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

    From date of rituximab commencement up to 2 years

    Time frame: 2 years

07

Study locations

1 site
  • Department of Medicine, The University of Hong Kong, Queen Mary Hospital
    Hong Kong, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01502397
Lead sponsor
The University of Hong Kong
Responsible party
Sponsor
First posted
Dec 30, 2011
Start date
Dec 2011
Primary completion
Dec 2015
Completion
Mar 2016
Last update
Oct 1, 2019

Study contacts

Man-Fung Yuen, FRCP
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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