ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B

A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00661076

Enrollment

Registered

2008-04-18

Start date

2008-08-31

Completion date

2011-05-31

Last updated

2016-11-02

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

Conditions

Hepatitis B, Chronic

Brief summary

This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Interventions

DRUGadefovir dipivoxil

10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)

DRUGpeginterferon alfa-2a [Pegasys]

180 micrograms weekly for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-70 years of age; * chronic hepatitis B; * positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months; * either nucleoside analogue naive, or has not received IFN-a in the past 6 months.

Exclusion criteria

* positive for hepatitis A, C, D or HIV; * history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B; * antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.

Design outcomes

Primary

Measure	Time frame
Normalization of ALT, and HBV-DNA <400 copies/mL	Week 96 for arm 1; week 48 for arms 2 and 3
HBsAg quantitative loss and anti-HBs seroconversion	Weeks 48, 96 and 144

Secondary

Measure	Time frame
AEs, lab parameters, vital signs	Throughtout study

Countries

Turkey (Türkiye)

Outcome results

None listed

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