CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study

Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00645736

Acronym

CHARM

Enrollment

788

Registered

2008-03-28

Start date

2008-02-29

Completion date

2008-11-30

Last updated

2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B

Brief summary

This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

Detailed description

This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy. It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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.

Design outcomes

Primary

Measure	Time frame
Descriptive statistics for clinical and viral characteristics of the study population	Single timepoint (blood draw)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026