Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
|ClinicalTrials.gov Identifier: NCT00403585|
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : November 24, 2010
Last Update Posted : December 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic Chronic Hepatitis B||Drug: adefovir dipivoxil 10mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
- Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy [ Time Frame: Baseline, Week 156 ]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 ]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 ]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 ]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 ]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) ]The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403585
|Korea, Republic of|
|GSK Investigational Site|
|Seoul, Korea, Republic of, 137-701|
|Study Director:||GSK Clinical Trials, M.D., Ph.D||GlaxoSmithKline|