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

March 10, 2017 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital; Internal Medicine
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
      • Kaohsiung, Taiwan, 00833
        • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
      • Keelung City, Taiwan, 204
        • Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
      • Taichung, Taiwan, 404
        • China Medical University Hospital; Department of Rheumatology
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital; Gastroenterology Division
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital; Gastro-Enterology Dept.
      • Taipei, Taiwan
        • Tri-Service Hospital; Dept. of Internal Medicine
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Adefovir
From week -4 to week 2
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48
Experimental: 2
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48
Drug: Entecavir
From week -4 to week 2
Placebo Comparator: 3
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48
Drug: Placebo
From week -4 to week 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
Time Frame: Week 100
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Week 100

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants Who Were HBeAg Negative
Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Time Frame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants With Combined Response
Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

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 (Actual)

May 7, 2010

Primary Completion (Actual)

September 29, 2014

Study Completion (Actual)

September 29, 2014

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21827

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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