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

Phase 3

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: AAAA; Drug: AAPA; Drug: PAAA

• Registration Number: NCT00857675
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-09
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-02
• Last Update Posted: 2009-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adefovir Dipivoxil	AAAA	ADV 10mg tablets once daily
Adefovir Dipivoxil	AAPA	ADV 10mg tablets once daily
Adefovir Dipivoxil	PAAA	ADV 10mg tablets once daily
Adefovir Dipivoxil matched placebo	AAPA	Adefovir Dipivoxil matched placebo one tablet once daily
Adefovir Dipivoxil matched placebo	PAAA	Adefovir Dipivoxil matched placebo one tablet once daily

Primary Outcome Measures

Name	Time	Method
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo	Week 12

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects with ALT normalisation	Week 52, 104, 156, 208, 260
log10 reduction in serum HBV DNA	Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level	Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg loss	Week 52, 104, 156, 208, 260
The proportion of subjects with HBeAg seroconversion	Week 52, 104, 156, 208, 260
The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance	Week 52, 104, 156, 208, 260
The proportion of subjects with HBV DNA undetectable (<300 copies/mL)	Week 52, 104, 156, 208, 260

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Shanghai, China