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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: PAAA; Drug: AAAA; Drug: AAPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857675

ADF30001

Details and patient eligibility

About

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.

Enrollment: 480 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups, including a placebo group

Adefovir Dipivoxil

Experimental group

Description:

ADV 10mg tablets once daily

Treatment:

Drug: AAPA

Drug: AAAA

Drug: PAAA

Adefovir Dipivoxil matched placebo

Placebo Comparator group

Description:

Adefovir Dipivoxil matched placebo one tablet once daily

Treatment:

Drug: AAPA

Drug: PAAA