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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01502397
First received: December 28, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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
Exposure to Hepatitis B Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • HBV reactivation (defined as detectable HBV DNA > 20 IU/mL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 70
Study Start Date: December 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
HBsAg-negative, anti-HBc-positive
HBsAg-negative, anti-HBc-positive subjects 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502397

Locations
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
Investigators
Principal Investigator: Man-Fung Yuen, FRCP The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01502397     History of Changes
Other Study ID Numbers: HKCTR-1431, HKCTR-1431
Study First Received: December 28, 2011
Last Updated: December 28, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
hepatitis B
anti-HBc
HBsAg
rituximab
occult HBV

Additional relevant MeSH terms:
Hepatitis
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
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014