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An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734018
First Posted: November 27, 2012
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 multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.

Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up [ Time Frame: from baseline to up to approximately 3 years ]
  • Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up [ Time Frame: from baseline to up to approximately 3 years ]

Secondary Outcome Measures:
  • Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients) [ Time Frame: approximately 4 years ]
  • Percentage of patients with normalisation of serum alanine transaminase (ALT) levels [ Time Frame: approximately 4 years ]
  • Percentage of patients with HBsAg clearance/seroconversion [ Time Frame: approximately 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

Enrollment: 50
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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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 receiving treatment with Pegasys
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
  • Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label

Exclusion Criteria:

  • Contra-indications to Pegasys as detailed in the label
  • Co-infection with hepatitis A, hepatitis B or HIV
  • Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
  • Pregnant or breastfeeding women
  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): NCT01734018


Locations
Germany
Berlin, Germany, 13353
Leipzig, Germany, 04103
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01734018     History of Changes
Other Study ID Numbers: ML25614
First Submitted: November 21, 2012
First Posted: November 27, 2012
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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs