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

NCT00489151 | Unknown

• 2 other identifiers: UW 04-315 T/637HARECCTR0500002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

HBV

Outcome Measures

Primary Outcomes (1)

• To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients

  72 weeks

Secondary Outcomes (1)

• To assess the safety of adefovir dipivoxil in HBV seropositive patients who are planned to undergo chemotherapy, as compared to lamivudine.

  72 weeks

Interventions

adefovir dipivoxil DRUG

lamivudine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• HCV+ HDV+

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Interventions

adefovir dipivoxil; Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• George Lau, Dr

  Department of Medicine, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chee-Kin Hui, Dr

CONTACT

(852) 2818 4300; ckh23@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 21, 2007
• Study Start: June 1, 2005
• Study Completion: December 1, 2007
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)