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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00441974 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: adefovir dipivoxil 10mg tablet |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 48-Week Multi-Centre, Open-Label, Local Phase IV Study to Demonstrate the Efficacy and Safety of Adefovir Dipivoxil Tablets (10mg) in Chinese Subjects With Compensated Chronic Hepatitis B |
Estimated Enrollment: | 1250 |
Study Start Date: | December 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
China | |
GSK Investigational Site | |
Shanghai, China, 200001 | |
GSK Investigational Site | |
Beijing, China, 100044 | |
GSK Investigational Site | |
Shanghai, China, 200003 | |
GSK Investigational Site | |
Shanghai, China, 200040 | |
GSK Investigational Site | |
Tianjin, China, 300192 | |
GSK Investigational Site | |
Changsha, China, 410011 | |
GSK Investigational Site | |
Chongqing, China, 400038 | |
GSK Investigational Site | |
Beijing, China, 100050 | |
GSK Investigational Site | |
Shanghai, China, 200025 | |
GSK Investigational Site | |
Shanghai, China, 200433 | |
GSK Investigational Site | |
Chongquin, China, 400038 | |
GSK Investigational Site | |
Fuzhou, China, 350025 | |
GSK Investigational Site | |
Changsha, China, 410008 | |
GSK Investigational Site | |
Beijing, China, 100069 | |
GSK Investigational Site | |
Jinan, China, 250021 | |
GSK Investigational Site | |
Beijing, China, 100011 | |
China, Guangdong | |
GSK Investigational Site | |
Guangzhou, Guangdong, China, 510630 | |
GSK Investigational Site | |
Guangzhou, Guangdong, China, 510515 | |
China, Hubei | |
GSK Investigational Site | |
Wuhan, Hubei, China, 430030 | |
China, Jiangsu | |
GSK Investigational Site | |
Nanjing, Jiangsu, China, 210003 | |
GSK Investigational Site | |
Nanjing, Jiangsu, China, 210002 | |
GSK Investigational Site | |
Nanjing, Jiangsu, China, 210029 | |
China, Jilin | |
GSK Investigational Site | |
Changchun, Jilin, China, 130021 | |
China, Sichuan | |
GSK Investigational Site | |
Chengdu, Sichuan, China, 610041 | |
China, Zhejiang | |
GSK Investigational Site | |
Hangzhou, Zhejiang, China, 310009 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ADF108356 |
Study First Received: | February 28, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00441974 |
Health Authority: | China: State Food and Drug Administration |
adefovir dipivoxil compensated chronic hepatitis B Chinese |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Hepatitis B Hepatitis, Viral, Human Adefovir dipivoxil DNA Virus Infections Adefovir |
Anti-Infective Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors |