A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
Information source: Hospital Authority, Hong Kong
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B
Intervention: adefovir dipivoxil (Drug); lamivudine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hospital Authority, Hong Kong Official(s) and/or principal investigator(s): George Lau, Dr, Principal Investigator, Affiliation: Department of Medicine, Queen Mary Hospital
Overall contact: Chee-Kin Hui, Dr, Phone: (852) 2818 4300, Email: ckh23@hku.hk
Summary
Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality
in hepatitis B infected patients treated with chemotherapy. We have previously shown that
with pre-emptive use of lamivudine, one can drastically reduce liver-related morbidity and
mortality in such patients. However, due to the development of hepatitis B virus resistance
to lamivudine, some of these hepatitis B infected patients still develop hepatitis. This is
a research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis
B infected patients treated with chemotherapy. Both of these drugs have been approved for
the treatment of the hepatitis B infection in the United States, European Union and Hong
Kong.
All patients who were recruited in this study will receive study medication, either
lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of
chemotherapy for 72 weeks. All patients will be follow-up for an additional 24 weeks
thereafter. Altogether, 70 subjects will be recruited from Queen Mary Hospital, Hong Kong
SAR.
This is an open-label study, which means that the patients and the study doctor will know
which treatment the subjects are assigned into. If a subject decides to take part in the
study and is found eligible, he/she will be randomly (like flipping of coin) assigned to one
of the following dose groups:
Lamivudine (100 mg) tablet Adefovir dipivoxil (10 mg) tablet
Clinical Details
Official title: A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients
Secondary outcome: To assess the safety of adefovir dipivoxil in HBV seropositive patients who are planned to undergo chemotherapy, as compared to lamivudine.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy
Exclusion Criteria:
- HCV+ HDV+
Locations and Contacts
Chee-Kin Hui, Dr, Phone: (852) 2818 4300, Email: ckh23@hku.hk
Queen Mary Hospital, Hong Kong, China; Recruiting Raymond Liang, Prof, Sub-Investigator Yok-Lam Kwong, Prof, Sub-Investigator Wing-Yan Au, Dr, Sub-Investigator Chor-sang Chim, Dr, Sub-Investigator Louis Chow, Dr, Sub-Investigator Chee-Kin Hui, Dr, Sub-Investigator
Additional Information
HAREC Clinical Trial Registry
Starting date: June 2005
Last updated: July 6, 2010
|