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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:
NCT01667432
First received: August 15, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

August 15, 2012
May 7, 2013
June 2011
September 2015   (final data collection date for primary outcome measure)
  • Percentage of patients with suppression of HBV DNA < 2,000 IU/ml [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • In HBeAg positive patients: Percentage of patients who become HBeAg negative and anti-HBe positive [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01667432 on ClinicalTrials.gov Archive Site
  • HBsAg clearance: Percentage of patients who become HBsAg negative [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg clearance with other on-treatment factors in HBeAg positive and HBeAg negative patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Correlation of HBsAg clearance with pre-treatment factors in HBeAg positive and HBeAg negative patients [ Time Frame: approximately 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of serum ALT normalization: serum ALT/ALT ratio [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
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, Observational, Non-Interventional Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with Pegasys (peginterferon alfa-2a) in accordance with local labelling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with chronic hepatitis B on 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
350
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HBeAg positive or HBeAg negative hepatitis B with or without cirrhosis
  • Elevated 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 C or HIV
  • Concomitant treatment with telbivudine
  • Pregnant or lactating women
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML25626 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Bulgaria
 
NCT01667432
ML25626
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