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

February 16, 2017 updated by: Hoffmann-La Roche

A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: C
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)
Experimental: B
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Experimental: D
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: entecavir
0.5 mg orally daily, 24 weeks (weeks 12-36)
Placebo Comparator: A
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 96 weeks
Drug: placebo
orally daily, 24 weeks (weeks 12-36)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Time Frame: 48 weeks after the end of treatment
48 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation early HBsAg response - response end of treatment/follow-up
Time Frame: every 6 weeks up to week 48, every 12 weeks therafter
every 6 weeks up to week 48, every 12 weeks therafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 18, 2010

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (Estimate)

August 11, 2010

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV22597
  • 2009-017602-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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