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

Completed

• Conditions: Exposure to Hepatitis B Virus

• Registration Number: NCT01502397
• Lead Sponsor: 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 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-28
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-30
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medicine, The University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong