Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study
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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 |
- 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 |
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)
Contacts and Locations| Hong Kong | |
| Department of Medicine, The University of Hong Kong, Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
| 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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013