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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B (CHB).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00435825
First received: February 15, 2007
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms sc weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Condition Intervention Phase
Hepatitis B, Chronic
 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, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HBeAg seroconversion [ Time Frame: At end of initial 24 week treatment-free follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loss of ABeAg, HBsAg seroconversion, loss of HBsAg, ALT, HBV-DNA. [ Time Frame: At end of 24 week treatment-free follow-up, and at week 72. ] [ Designated as safety issue: No ]
  • HBeAg seroconversion [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 551
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
90 micrograms sc weekly for 24 weeks.
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks
Experimental: 3 Drug: peginterferon alfa-2a [Pegasys]
90 micrograms sc weekly for 48 weeks
Experimental: 4 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • positive HBsAg for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
  • liver disease consistent with CHB.

Exclusion Criteria:

  • antiviral therapy for CHB within previous 6 months;
  • co-infection with HAV, HCV, HDV or HIV;
  • evidence of decompensated liver disease;
  • medical condition associated with chronic liver disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435825

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00435825     History of Changes
Other Study ID Numbers: WV19432
Study First Received: February 15, 2007
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013