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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00489151
First received: June 20, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes

June 20, 2007
July 6, 2010
June 2005
Not Provided
To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients [ Time Frame: 72 weeks ]
Same as current
Complete list of historical versions of study NCT00489151 on ClinicalTrials.gov Archive Site
To assess the safety of adefovir dipivoxil in HBV seropositive patients who are planned to undergo chemotherapy, as compared to lamivudine. [ Time Frame: 72 weeks ]
Same as current
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Not Provided
 
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

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
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
  • Drug: adefovir dipivoxil
  • Drug: lamivudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • HCV+ HDV+
Both
18 Years to 70 Years
Not Provided
Contact: Chee-Kin Hui, Dr (852) 2818 4300 ckh23@hku.hk
China
 
NCT00489151
UW 04-315 T/637, HARECCTR0500002
Not Provided
Not Provided
Hospital Authority, Hong Kong
The University of Hong Kong
Principal Investigator: George Lau, Dr Department of Medicine, Queen Mary Hospital
Hospital Authority, Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP