Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
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.
Hepatitis B, Chronic
Chronic Hepatitis B
Drug: adefovir dipivoxil 10mg
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV, Open Label, Single Arm, Multicenter, Extension Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814|
- Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy [ Time Frame: Baseline, Week 156 ] [ Designated as safety issue: No ]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.
- Number of Participants Achieving ALT Normalization at Week 104 & 156 [ Time Frame: Week 104, Week 156 ] [ Designated as safety issue: No ]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.
- Number of Participants Achieving Virological Response at Week 104 & 156 [ Time Frame: Week 104, Week 156 ] [ Designated as safety issue: No ]Virological response is defined as HBV DNA level<300 copies/ml
- HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 [ Time Frame: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156 ] [ Designated as safety issue: No ]Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
- Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 [ Time Frame: Week 104 and 156 ] [ Designated as safety issue: No ]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.
- Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event [ Time Frame: Treatment Phase (Weeks 53-156) ] [ Designated as safety issue: No ]The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
|Study Start Date:||July 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Drug: adefovir dipivoxil 10mg
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403585
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 137-701|
|Study Director:||GSK Clinical Trials, M.D., Ph.D||GlaxoSmithKline|