Back to resultsADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
adefovir dipivoxil
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Normalization of ALT, and HBV-DNA <400 copies/mL
HBsAg quantitative loss and anti-HBs seroconversion
Secondary Outcome Measures
AEs, lab parameters, vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661076
Brief Title
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Official 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.'
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
adefovir dipivoxil
Intervention Description
10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2)
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms weekly for 48 weeks
Primary Outcome Measure Information:
Title
Normalization of ALT, and HBV-DNA <400 copies/mL
Time Frame
Week 96 for arm 1; week 48 for arms 2 and 3
Title
HBsAg quantitative loss and anti-HBs seroconversion
Time Frame
Weeks 48, 96 and 144
Secondary Outcome Measure Information:
Title
AEs, lab parameters, vital signs
Time Frame
Throughtout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Ankara
ZIP/Postal Code
06018
Country
Turkey
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
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