This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with HBeAg negative chronic hepatitis B

NCT00324961

Conditions

1. Chronic Hepatitis B

Interventions

1. Drug: adefovir dipivoxil tablets

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. --- N236T --- --- A181V ---

This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB. Primary endpoint is proportion of subjects achieving HBV DNA undetectable (<=1000 copies/mL by by Roche COBAS AMPLICOR HBV MONITOR Test) at week 48. Approximately 1250 patients will be recruited in 30 study centers in China. The subjects are offered 48 weeks of open label adefovir dipivoxil treatment, with assessments every three months, after with is a 12-week post study treatment follow-up prior to study completion.

NCT00441974

Conditions

1. Chronic Hepatitis B

Interventions

1. Drug: adefovir dipivoxil

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

Week 48 serum samples from participants, who reached a HBV DNA breakthrough or have HBV DNA≥5 log copies/mL at Weeks 24 and 48 were assessed for the development of ADV (Adefovir dipivoxil) mutation (N236T and A181V) in the HBV polymerase. --- N236T --- --- A181V ---

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.

NCT00857675

Conditions

1. Chronic Hepatitis B

Interventions

1. Drug: AAAA
2. Drug: AAPA
3. Drug: PAAA

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

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.

NCT00962533

Conditions

1. Hepatitis B, Chronic

Interventions

1. Drug: telbivudine
2. Drug: telbivudine

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis

HPO:Hepatitis

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 A Hepatitis B Hepatitis B, Chronic Hepatitis 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 A Hepatitis B Hepatitis B, Chronic Hepatitis 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

NCT01341743

Conditions

1. Hepatitis B

Interventions

1. Drug: Entecavir
2. Drug: Entecavir, Adefovir
3. Drug: Entecavir, Adefovir

MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic

HPO:Chronic active hepatitis Chronic hepatitis Hepatitis

The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104. --- A181V ---