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

Exposure to Hepatitis B Virus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502397
• Other study ID #: HKCTR-1431
• Secondary ID: HKCTR-1431
• Status: Completed
• Start date: December 2011
• Est. completion date: March 2016

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exposure to Hepatitis B Virus
• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, The University of Hong Kong, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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