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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
November 21, 2012
November 27, 2012
November 2, 2016
August 2011
August 2012   (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 ]
  • 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 ]
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 ]
  • 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 ]
Same as current
Not Provided
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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.
 
Completed
50
August 2012
August 2012   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01734018
ML25614
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016