Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000366459
Ethics application status
Approved
Date submitted
10/07/2007
Date registered
12/07/2007
Date last updated
14/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
Scientific title
An Observational Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy.
Universal Trial Number (UTN)
Trial acronym
CHARM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 1944 0
Condition category
Condition code
Inflammatory and Immune System 2041 2041 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-Interventional
Intervention code [1] 1883 0
None
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2867 0
A description of the prevalence and nature of hepatitis B virus mutations detectable in subjects managed in the naturalistic setting in Australia
Timepoint [1] 2867 0
At the time of recruitment into the study.
Secondary outcome [1] 4834 0
Investigate relationships between demographic, and retrospective clinical (including treatment) related factors and the detection of specific viral mutation profiles at the time of enrolment.
Timepoint [1] 4834 0
At the time of enrolment
Secondary outcome [2] 4835 0
Establish the lower limit if hepatitis B viral load at which deoxyribonucleic acid (DNA) sequence analysis of the catalytic region of the hepatitis B virus polymerase (encoding amino acids 1-257 and 75-257) can be performed.
Timepoint [2] 4835 0
Analysis will be carried out at one single time-point

Eligibility
Key inclusion criteria
Provided informed consent-Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)-Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management-Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment-Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 yearsKey
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D-Concomitant immunosuppression / immunomodulator therapies-Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months-Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial -Current Child Pugh class C classification (current Child Pugh score > 9)-Other known or suspected cause of chronic liver disease-Any other reason that, in the investigator’s opinion, participation in the study would not be in the participant’s best interest.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2183 0
Commercial sector/Industry
Name [1] 2183 0
Gilead Sciences Pty Ltd
Country [1] 2183 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences Pty Ltd
Address
Gilead Sciences Pty Ltd Level 1 128 Jolimont Road East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 1970 0
None
Name [1] 1970 0
N/A
Address [1] 1970 0
Country [1] 1970 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Clinical experience has shown continued use of antiviral medication to treat hepatitis B can lead to changes or ‘mutations’ in the hepatitis B virus (or HBV). The virus, once it has ‘mutated’, might then be resistant to the particular medication previously taken, and a new hepatitis B medication is needed to mange the infection. If the infection is not managed with effective medication liver damage can occur. Early detection of hepatitis B mutations can enable doctors to manage hepatitis B treatment before further liver damage can occur.

The purpose of this project is to describe the mutations in the hepatitis B virus in Australian patients with hepatitis B. Further, it aims to investigate the relationships between demographic and clinical factors to the appearance of these viral mutations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27697 0
Address 27697 0
Country 27697 0
Phone 27697 0
Fax 27697 0
Email 27697 0
Contact person for public queries
Name 11072 0
Amanda Elsome
Address 11072 0
Gilead Sciences Pty Ltd
Level 1, 128 Jolimont Road
East Melbourne VIC 3002
Country 11072 0
Australia
Phone 11072 0
+61 3 9272 4433
Fax 11072 0
+61 3 9272 4435
Email 11072 0
[email protected]
Contact person for scientific queries
Name 2000 0
Amanda Elsome
Address 2000 0
Gilead Sciences Pty Ltd
Level 1
128 Jolimont Road
East Melbourne VIC 3002
Country 2000 0
Australia
Phone 2000 0
+61 3 9272 4433
Fax 2000 0
+61 3 9272 4435
Email 2000 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.