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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01734018
First received: November 21, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

November 21, 2012
May 7, 2013
August 2011
June 2016   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01734018 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with normalisation of serum alanine transaminase (ALT) levels [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Percentage of patients with HBsAg clearance/seroconversion [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with chronic hepatitis B receiving treatment with Pegasys
Hepatitis B, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML25614 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Germany
 
NCT01734018
ML25614
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP