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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922207
First received: June 16, 2009
Last updated: October 20, 2015
Last verified: October 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Combined Response [ Time Frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 ] [ Designated as safety issue: No ]
    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
Study Start Date: May 2010
Study Completion Date: September 2014
Primary Completion Date: September 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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922207

Locations
Taiwan
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 807
Keelung City, Taiwan, 204
Taichung, Taiwan, 404
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taipei, Taiwan
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 
Study First Received: June 16, 2009
Results First Received: October 20, 2015
Last Updated: October 20, 2015
Health Authority: Taiwan:DOH

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

ClinicalTrials.gov processed this record on September 28, 2016