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

Primary Purpose

Hepatitis B

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

adefovir dipivoxil

lamivudine

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring HBV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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

Exclusion Criteria:

HCV+ HDV+

Sites / Locations

Queen Mary HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00489151

First Posted

June 20, 2007

Last Updated

July 6, 2010

Sponsor

Hospital Authority, Hong Kong

Collaborators

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00489151

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Authority, Hong Kong

Collaborators

The University of Hong Kong

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

HBV

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

adefovir dipivoxil

Intervention Type

Drug

Intervention Name(s)

lamivudine

Primary Outcome Measure Information:

Title

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

Time Frame

72 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Eligibility Criteria

Inclusion Criteria: HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy Exclusion Criteria: HCV+ HDV+

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chee-Kin Hui, Dr

Phone

(852) 2818 4300

ckh23@hku.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Lau, Dr

Organizational Affiliation

Department of Medicine, Queen Mary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raymond Liang, Prof

First Name & Middle Initial & Last Name & Degree

Yok-Lam Kwong, Prof

First Name & Middle Initial & Last Name & Degree

Wing-Yan Au, Dr

First Name & Middle Initial & Last Name & Degree

Chor-sang Chim, Dr

First Name & Middle Initial & Last Name & Degree

Louis Chow, Dr

First Name & Middle Initial & Last Name & Degree

Chee-Kin Hui, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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