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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01502397
Recruitment Status : Unknown
Verified December 2014 by The University of Hong Kong.
Recruitment status was:  Enrolling by invitation
First Posted : December 30, 2011
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):
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.

Condition or disease
Exposure to Hepatitis B Virus

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 Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. HBV reactivation (defined as detectable HBV DNA > 20 IU/mL) [ Time Frame: 2 years ]
    From date of rituximab commencement up to 2 years

Biospecimen Retention:   Samples Without DNA
Serum and plasma for hepatitis B virus genotypic, virologic and serologic testing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01502397

Hong Kong
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Man-Fung Yuen, FRCP The University of Hong Kong

Responsible Party: The University of Hong Kong Identifier: NCT01502397     History of Changes
Other Study ID Numbers: HKCTR-1431
HKCTR-1431 ( Registry Identifier: HKU CTC )
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by The University of Hong Kong:
hepatitis B
occult HBV

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents