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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283074
First Posted: January 25, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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:


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 ]

Secondary Outcome Measures:
  • Normalization of serum alanine aminotransferase [ Time Frame: 12 months ]
  • Safety (Incidence of adverse events) [ Time Frame: 12 months ]

Enrollment: 107
Study Start Date: May 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283074


Locations
Greece
Alexandroupolis, Greece, 68100
Athens, Greece, 10676
Athens, Greece, 115 27
Athens, Greece, 11521
Athens, Greece, 11527
Athens, Greece, 11528
Athens, Greece, 124 61
Larissa, Greece, 41 110
Patra, Greece, 265 04
Piraeus, Greece, 18454
Piraeus, Greece, 18536
Rhodes, Greece, 85100
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 56429
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01283074     History of Changes
Other Study ID Numbers: ML22016
First Submitted: January 24, 2011
First Posted: January 25, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

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
Antiviral Agents
Anti-Infective Agents