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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922207
First Posted: June 17, 2009
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic Drug: Adefovir Drug: Entecavir Drug: Placebo Drug: peginterferon alfa-2a [Pegasys] Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.

  • Percentage of Participants Who Were HBeAg Negative [ Time Frame: 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 ]
  • 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).

  • 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 ]
  • 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).


Enrollment: 280
Actual Study Start Date: May 7, 2010
Study Completion Date: September 29, 2014
Primary Completion Date: September 29, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Entecavir
From week -4 to week 2
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48
Placebo Comparator: 3 Drug: Placebo
From week -4 to week 2
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly, from week 1-48

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922207


Locations
Taiwan
Changhua Christian Hospital; Internal Medicine
Changhua, Taiwan, 500
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung, Taiwan, 00833
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung, Taiwan, 807
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung City, Taiwan, 204
China Medical University Hospital; Department of Rheumatology
Taichung, Taiwan, 404
National Taiwan Uni Hospital; Gastro-Enterology Dept.
Taipei, Taiwan, 100
Taipei Veterans General Hospital; Gastroenterology Division
Taipei, Taiwan, 112
Tri-Service Hospital; Dept. of Internal Medicine
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922207     History of Changes
Other Study ID Numbers: ML21827
First Submitted: June 16, 2009
First Posted: June 17, 2009
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: April 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Entecavir
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents