A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Adefovir; Adefovir dipivoxil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.