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Completed

NCT Number: NCT00661076

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adefovir dipivoxil

Drug

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

peginterferon alfa-2a [Pegasys]

Drug

180 micrograms weekly for 48 weeks

Primary outcomes

  1. Normalization of ALT, and HBV-DNA <400 copies/mL

    Time frame: Week 96 for arm 1; week 48 for arms 2 and 3

  2. HBsAg quantitative loss and anti-HBs seroconversion

    Time frame: Weeks 48, 96 and 144

Secondary outcomes

  1. AEs, lab parameters, vital signs

    Time frame: Throughtout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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.'

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 18, 2008
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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