A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) 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:
NCT01519921
First received: January 5, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa- 2a) in patients with HBeAg positive chronic hepatitis B. Patients will be strati fied into group A (treatment naïve patients) or B (YMDD mutant patients). All p atients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 we eks, followed by 24 weeks of treatment-free follow up.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) 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 patients with hepatitis B virus DNA <100,000 copies/mL [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with hepatitis B virus HBeAg loss rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with hepatitis B virus (HBV) DNA below limit of detection [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with a combined response of HBeAg seroconversion, loss of HBeAg, and alanine aminotransferase normalization [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg seroconversion [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with loss of HBsAg [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with loss of HBsAg and presence of anti-HBs [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with alanine aminotransferase (ALT) normalization [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: peginterferon alfa-2a [Pegasys]
Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

  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
  • HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
  • Detectable HBV DNA (>100,000 copies/mL)

Exclusion Criteria:

  • Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease
  • A medical condition associated with chronic liver disease other than viral hepatitis
  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: NCT01519921

Locations
Korea, Republic of
Daegu, Korea, Republic of, 700-721
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519921     History of Changes
Other Study ID Numbers: ML18495
Study First Received: January 5, 2012
Last Updated: October 20, 2014
Health Authority: Korea: Korea Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014