There are 3 clinical trials
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance. --- N236T --- --- A181V ---
The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
Inclusion Criteria: - Male or female, from 18 (inclusive) to 65 (inclusive) years of age - HBsAg and HBeAg positive for over six months - Patient is willing and able to comply with the study drug regimen and all other study requirements - Patients must give written informed consent before any assessment is performed Exclusion Criteria: - Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit - Patient has a history of or clinical signs/symptoms of hepatic decompensation - Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC - Other protocol-defined inclusion/exclusion criteria may apply Inclusion Criteria: - Male or female, from 18 (inclusive) to 65 (inclusive) years of age - HBsAg and HBeAg positive for over six months - Patient is willing and able to comply with the study drug regimen and all other study requirements - Patients must give written informed consent before any assessment is performed Exclusion Criteria: - Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit - Patient has a history of or clinical signs/symptoms of hepatic decompensation - Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC - Other protocol-defined inclusion/exclusion criteria may apply Hepatitis B, Chronic Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T --- --- A181V ---
Inclusion Criteria: - Male or female, from 18 (inclusive) to 65 (inclusive) years of age - HBsAg and HBeAg positive for over six months - Patient is willing and able to comply with the study drug regimen and all other study requirements - Patients must give written informed consent before any assessment is performed Exclusion Criteria: - Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit - Patient has a history of or clinical signs/symptoms of hepatic decompensation - Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC - Other protocol-defined inclusion/exclusion criteria may apply Inclusion Criteria: - Male or female, from 18 (inclusive) to 65 (inclusive) years of age - HBsAg and HBeAg positive for over six months - Patient is willing and able to comply with the study drug regimen and all other study requirements - Patients must give written informed consent before any assessment is performed Exclusion Criteria: - Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit - Patient has a history of or clinical signs/symptoms of hepatic decompensation - Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC - Other protocol-defined inclusion/exclusion criteria may apply Hepatitis B, Chronic Hepatitis Hepatitis A Hepatitis B Hepatitis B, Chronic null --- M204I --- --- N236T --- --- A181V --- --- M204I --- --- N236T --- --- A181V ---
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104. --- A181V ---