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

A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857675

Enrollment

480

Registered

2009-03-09

Start date

2002-12-31

Completion date

2008-03-31

Last updated

2009-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

HBV DNA suppression, ALT normalisation, Viral resistance, HBeAg seroconversion

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.

Interventions

DRUGAAAA

Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)

DRUGAAPA

Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)

DRUGPAAA

Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 ALT normalisation	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
The proportion of subjects with HBeAg seroconversion	Week 52, 104, 156, 208, 260

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026