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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: November 24, 2014
Last verified: November 2014
  Purpose

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in com bination with Adefovir or Entecavir in patients with HBeAg positive chronic hepa titis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc week ly 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 week ly 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:
  • HBeAg seroconversion [ Time Frame: At end of follow-up (week 76) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBV DNA; loss of HBeAg; ALT normalization [ Time Frame: Weeks 52 and 76 ] [ Designated as safety issue: No ]
  • HbsAg measurement [ Time Frame: Baseline, weeks 4,8,16,28,40,52,76 ] [ Designated as safety issue: No ]
  • Adverse events, vital signs, laboratory parameters [ Time Frame: At planned visits up to week 52;week 76 ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
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, 807
Kaohsiung, Taiwan, 00833
Keelung City, Taiwan, 204
Taichung, Taiwan, 404
Taipei, Taiwan, 100
Taipei, Taiwan
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00922207     History of Changes
Other Study ID Numbers: ML21827
Study First Received: June 16, 2009
Last Updated: November 24, 2014
Health Authority: Taiwan:DOH

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

ClinicalTrials.gov processed this record on November 24, 2014