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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00324961 |
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
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis B |
Drug: adefovir dipivoxil tablets |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 2-Year Multi-Centre, Open-Label, Local Phase IV Study to Demonstrate the Efficacy and Safety of Adefovir Dipivoxil Tablets (10mg) in Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B |
Estimated Enrollment: | 500 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following laboratory and clinical parameters at study screening:
A female is eligible to enter and participate in this study if she is of:
Exclusion Criteria:
Documented evidence of active liver disease due to other causes including co-infection hepatitis C (HCV), Subjects who are anti-HCV positive and in whom HCV RNA is undetectable are considered to be HCV seropositive and will not eligible;
co-infection with hepatitis delta (HDV);
co-infection with HIV;
autoimmune hepatitis (antinuclear antibody titre > 1:160)
serum bilirubin > 2.5 mg/dL (≤ 43 µmol/L) - prothrombin time > 2 second prolonged above ULN
history of ascites, variceal bleeding, or encephalopathy
- where no positive ultrasound finding, but serum alpha-fetoprotein > 100ng/mL
China | |
GSK Investigational Site | |
Beijing, China, 100011 | |
GSK Investigational Site | |
Chongqing, China, 400038 | |
GSK Investigational Site | |
Shanghai, China, 200025 | |
GSK Investigational Site | |
Shanghai, China, 200433 | |
GSK Investigational Site | |
Shanghai, China, 200040 | |
GSK Investigational Site | |
Shanghai, China, 200003 | |
GSK Investigational Site | |
Shanghai, China, 200001 | |
GSK Investigational Site | |
Beijing, China, 100044 | |
GSK Investigational Site | |
Chongquin, China, 400038 | |
GSK Investigational Site | |
Changsha, China, 410008 | |
GSK Investigational Site | |
Beijing, China, 100050 | |
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, 210029 | |
China, Jilin | |
GSK Investigational Site | |
Changchun, Jilin, China, 130021 | |
China, Shandong | |
GSK Investigational Site | |
Jinan, Shandong, China | |
China, Zhejiang | |
GSK Investigational Site | |
Hangzhou, Zhejiang, China, 310009 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | ADF106632 |
Study First Received: | May 9, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00324961 |
Health Authority: | China: State Food and Drug Administration |
adefovir dipivoxil e Antigen negative 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 |