The Extension Study

Phase 4

Recruiting

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

• Registration Number: ACTRN12606000283572
• Lead Sponsor: Prof. Meng Ngu, Concord Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Comment: Since this study is an extension study to studies 437/438/480, minimal inclusion/exclusion criteria apply. (The original study included both male and female participants over the age of 18 years). Inclusion:• Participation in and completion of study GS-98-437, GS-98-438 or GS-00-480.• Currently treated with adefovir dipivoxil 10mg once a day.

Exclusion Criteria

Pregnant or breastfeeding females• Known hypersensitivity to adefovir, adefovir dipivoxil, or any of the excipients in adefovir dipivoxil tablets.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Treatment Failures, defined as:<br>• Virologic failure, defined as increase in Hepatitis B Virus Deoxyribonucleid Acid (HBV DNA) by = 1 log10 copies/ml detected on two consecutive, separate occasions[Followed-up every 3 months, for the period of 5 years.];Proportion of Treatment Failures, defined as:<br>• Development of genotypic resistance, defined as detection of mutations associated with adefovir resistance (N236T; A181V)[Followed-up every 3 months, for the period of 5 years.];Proportion of Treatment Failures, defined as:<br>• Clinical resistance, defined as continuous alanine aminotransferase (ALT) elevation (> 2 x upper limit of normal [ULN]) measured at two consecutive, separate occasions.[Followed-up every 3 months, for the period of 5 years.]

Secondary Outcome Measures

Name	Time	Method
ALT normalisation and mean change from baseline[Measured every 3 months.];Proportion of patients with serum HBV DNA at or below the assay lower limit of quantification[Measured every 3 months.];Incidence of drug resistant mutations[Measured every 3 months.];Proportion of patients with HBsAg/HBeAg loss and seroconversion[Measured every 3 months.];Mean change in HBV DNA from baseline[Measured every 3 months.];Liver histology (if performed)[Measured at the end of the study (5 years).]