A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-07

Study Completion Date

2014-09-29

Brief Summary

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This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

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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

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Adefovir

Intervention Type DRUG

From week -4 to week 2

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms sc weekly, from week 1-48

2

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

From week -4 to week 2

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms sc weekly, from week 1-48

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

From week -4 to week 2

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms sc weekly, from week 1-48

Interventions

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Adefovir

From week -4 to week 2

Intervention Type DRUG

Entecavir

From week -4 to week 2

Intervention Type DRUG

Placebo

From week -4 to week 2

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc weekly, from week 1-48

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-65 years of age;
* HBeAg+ve for \>=3 months;
* positive serum HBV DNA within 3 months prior to entry;
* patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
* \>=3 months treatment-free interval from nucleotide analogues.

Exclusion Criteria

* evidence of decompensated liver disease;
* history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
* co-infection with active hepatitis A,C or D, or HIV.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No