Status:
COMPLETED
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
Lead Sponsor:
GlaxoSmithKline
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Aged 18-65 years
- Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
- Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
- Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.
Exclusion
- Evidence of hepatocellular carcinoma;
- Clinical signs of liver decompensation;
- Serum creatinine more than 1.5 mg/dL;
- ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
- Lamivudine therapy within 3 months prior to screening;
- ADV therapy or any other anti-HBV therapy within the previous 6 months;
- Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00857675
Start Date
December 1 2002
End Date
March 1 2008
Last Update
April 3 2009
Active Locations (10)
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1
GSK Investigational Site
Guangzhou, Guangdong, China, 510515
2
GSK Investigational Site
Guangzhou, Guangdong, China, 510630
3
GSK Investigational Site
Changchun, Jilin, China, 130021
4
GSK Investigational Site
Jinan, Shandong, China