A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-18

Study Completion Date

2014-11-30

Brief Summary

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This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \<500 patients.

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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

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type PLACEBO_COMPARATOR

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly, 48 weeks

placebo

Intervention Type DRUG

orally daily, 24 weeks (weeks 12-36)

B

Group Type EXPERIMENTAL

entecavir

Intervention Type DRUG

0.5 mg orally daily, 24 weeks (weeks 12-36)

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly, 48 weeks

C

Group Type PLACEBO_COMPARATOR

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly, 96 weeks

placebo

Intervention Type DRUG

orally daily, 24 weeks (weeks 12-36)

D

Group Type EXPERIMENTAL

entecavir

Intervention Type DRUG

0.5 mg orally daily, 24 weeks (weeks 12-36)

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly, 96 weeks

Interventions

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entecavir

0.5 mg orally daily, 24 weeks (weeks 12-36)

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

180 mcg sc weekly, 48 weeks

Intervention Type DRUG

peginterferon alfa-2a [Pegasys]

180 mcg sc weekly, 96 weeks

Intervention Type DRUG

placebo

orally daily, 24 weeks (weeks 12-36)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/= 18 years of age
* chronic hepatitis B for \>/= 6 months
* HBeAg negative at screening
* adequate renal function

Exclusion Criteria

* antiviral therapy for chronic hepatitis B within the previous 6 months
* hepatitis A, C, D or HIV infection
* treatment with systemic acyclovir or famciclovir within the previous 6 months
* decompensated liver disease (Childs B-C)
* history or evidence of a medical condition associated with chronic liver disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No