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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

Page last updated: August 20, 2015

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