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

Not Applicable

Recruiting

• Conditions: Chronic Hepatitis B; Inflammatory and Immune System - Liver

• Registration Number: ACTRN12607000366459
• Lead Sponsor: Gilead Sciences Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified