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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12607000366459

Acronym

CHARM

Enrollment

800

Registered

2007-07-12

Start date

2007-08-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

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.

Interventions

Non-Interventional

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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.

Outcome results