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
  Purpose

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


Condition Intervention
Hepatitis B
Drug: adefovir dipivoxil
Drug: lamivudine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients [ Time Frame: 72 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: June 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • HCV+ HDV+
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489151

Contacts
Contact: Chee-Kin Hui, Dr (852) 2818 4300 ckh23@hku.hk

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China
Sub-Investigator: 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         
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: George Lau, Dr Department of Medicine, Queen Mary Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00489151     History of Changes
Other Study ID Numbers: UW 04-315 T/637, HARECCTR0500002
Study First Received: June 20, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
HBV

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Lamivudine
Adefovir
Adefovir dipivoxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014