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

November 1, 2016 updated by: Hoffmann-La Roche

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.'

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
      • Ankara, Turkey, 06500
      • Ankara, Turkey, 06800
      • Ankara, Turkey, 06018
      • Gaziantep, Turkey, 27310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: adefovir dipivoxil
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks
Experimental: 2
Drug: adefovir dipivoxil
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks
Active Comparator: 3
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 48 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, lab parameters, vital signs
Time Frame: Throughtout study
Throughtout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20622

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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