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An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HbeAg-negative Chronic Hepatitis B (Perseas)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01283074
First received: January 24, 2011
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

This observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of Pegasys (peginterferon alfa-2a) in patients with HbeAg-negative chronic hepatitis B. Data will be collected for 96 weeks.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Factors of Long-term Response to Treatment With Pegylated Interferon Alfa-2a in Patients With HbeAg-negative Chronic Hepatitis B. (Perseas)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with combined (virological and biochemical) response [ Time Frame: 48 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normalization of serum alanine aminotransferase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety (Incidence of adverse events) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: May 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis B on treatment with Pegasys

Criteria

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of HBeAg-negative chronic hepatitis B with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis

Exclusion Criteria:

  • Co-infection with hepatitis A, C or D
  • Co-infection with human immunodeficiency virus (HIV)
  • Severe hepatic dysfunction or decompensated liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283074

Locations
Greece
Alexandroupolis, Greece, 68100
Athens, Greece, 11521
Athens, Greece, 11527
Athens, Greece, 11528
Athens, Greece, 10676
Athens, Greece, 124 61
Larissa, Greece, 41110
Patra, Greece, 265 04
Piraeus, Greece, 18454
Piraeus, Greece, 18536
Rhodes, Greece, 85100
Thessaloniki, Greece, 57010
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 54642
Thessaloniki, Greece, 56429
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: NCT01283074     History of Changes
Other Study ID Numbers: ML22016
Study First Received: January 24, 2011
Last Updated: April 1, 2013
Health Authority: Greece: Ministry of Health and Welfare

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013