A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

NCT ID: NCT00489151

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-12-31

Brief 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

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

adefovir dipivoxil

Intervention Type: DRUG

lamivudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy

Exclusion Criteria

• HCV+ HDV+

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: lead

Principal Investigators

George Lau, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Queen Mary Hospital

Locations

Queen Mary Hospital

Hong Kong, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chee-Kin Hui, Dr

Role: CONTACT

ckh23@hku.hk

(852) 2818 4300

Other Identifiers

HARECCTR0500002

Identifier Type: -

Identifier Source: secondary_id

UW 04-315 T/637

Identifier Type: -

Identifier Source: org_study_id