A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-12-31

Brief Summary

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This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

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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

NONE

Study Groups

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Peginterferon alfa-2a + entecavir

Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.

Group Type EXPERIMENTAL

entecavir

Intervention Type DRUG

0.5mg po daily for 8 weeks

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 micrograms sc/week for 48 weeks

Entecavir

Participants received entecavir 0.5 mg orally once daily for 48 weeks.

Group Type ACTIVE_COMPARATOR

entecavir

Intervention Type DRUG

0.5mg po daily for 48 weeks

Interventions

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entecavir

0.5mg po daily for 8 weeks

Intervention Type DRUG

entecavir

0.5mg po daily for 48 weeks

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc/week for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>=18 and \</= 65 years of age
* HBeAg positive chronic hepatitis B
* Pre-treatment with entecavir for 9-36 months

Exclusion Criteria

* Antiviral, antineoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, C or D, or HIV
* Evidence of decompensated liver disease
* History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No