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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
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.