This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
GSK Investigational Site
Seoul, South Korea
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
Time frame: Baseline, Week 156
Number of Participants Achieving ALT Normalization at Week 104 & 156
Alanine aminotransferase (ALT) normalization is defined as a value \<= upper limit of normal (ULN) range based on the set of subjects with ALT\>ULN at baseline. The normal range for ALT is 0-40 Units/Liter.
Time frame: Week 104, Week 156
Number of Participants Achieving Virological Response at Week 104 & 156
Virological response is defined as HBV DNA level\<300 copies/ml
Time frame: Week 104, Week 156
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
Time frame: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody \[HBeAb\] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody \[HBsAb\] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively.
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Time frame: Week 104 and 156
Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event
The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
Time frame: Treatment Phase (Weeks 53-156)