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

NCT ID: NCT00661076

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

adefovir dipivoxil

Intervention Type DRUG

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

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms weekly for 48 weeks

2

Group Type EXPERIMENTAL

adefovir dipivoxil

Intervention Type DRUG

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

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms weekly for 48 weeks

3

Group Type ACTIVE_COMPARATOR

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms weekly for 48 weeks

Interventions

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adefovir dipivoxil

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

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms weekly for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ankara, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ML20622

Identifier Type: -

Identifier Source: org_study_id