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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00645736




Registration number
NCT00645736
Ethics application status
Date submitted
25/03/2008
Date registered
28/03/2008
Date last updated
22/11/2011

Titles & IDs
Public title
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
Scientific title
Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
Secondary ID [1] 0 0
GS-AU-103-0185
Universal Trial Number (UTN)
Trial acronym
CHARM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

1 - Single cohort


Other interventions: No intervention
No intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Descriptive statistics for clinical and viral characteristics of the study population
Timepoint [1] 0 0
Single timepoint (blood draw)

Eligibility
Key inclusion criteria
- Aged 18 years and over

- 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
years
Minimum age
18 Years
Maximum age
No limit
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 / immunomodulatory 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
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
788
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Gilead Sciences Pty Ltd - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study has the aim of describing viral mutation profiles in patients diagnosed with
chronic hepatitis B receiving antihepadnaviral therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00645736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Howard Wraight
Address 0 0
Gilead Sciences Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00645736