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Sponsored by: |
GlaxoSmithKline |
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 |
MedlinePlus related topics: | Hepatitis Hepatitis B |
ChemIDplus related topics: | Hepatitis B Vaccines Adefovir dipivoxil Adefovir |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, 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 Clinical Trials Call Center | |||||
Beijing, China, 100034 | |||||
GSK Clinical Trials Call Center | |||||
Guangzhou, China, 510515 | |||||
GSK Clinical Trials Call Center | |||||
Guangzhou, China, 510630 | |||||
GSK Clinical Trials Call Center | |||||
Chongqing, China, 400038 | |||||
GSK Clinical Trials Call Center | |||||
Chongqing, China, 400010 | |||||
GSK Clinical Trials Call Center | |||||
Jinan, China, 250021 | |||||
GSK Clinical Trials Call Center | |||||
Hangzhou, China, 310003 | |||||
GSK Clinical Trials Call Center | |||||
Changchun, China, 130021 | |||||
GSK Clinical Trials Call Center | |||||
Nanjing, China, 210029 | |||||
GSK Clinical Trials Call Center | |||||
Wuhan, China, 430030 | |||||
GSK Clinical Trials Call Center | |||||
Beijing, China, 100050 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200335 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200001 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200025 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200003 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200040 | |||||
GSK Clinical Trials Call Center | |||||
Shanghai, China, 200433 | |||||
GSK Clinical Trials Call Center | |||||
Changsha, China, 410008 | |||||
GSK Clinical Trials Call Center | |||||
Beijing, China, 100011 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trial, MD | GlaxoSmithKline |
Study ID Numbers: | ADF106632 |
First Received: | May 9, 2006 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00324961 |
Health Authority: | China: State Food and Drug Administration |
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