An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01794234
First received: February 15, 2013
Last updated: September 22, 2014
Last verified: September 2014

February 15, 2013
September 22, 2014
August 2012
September 2013   (final data collection date for primary outcome measure)
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01794234 on ClinicalTrials.gov Archive Site
  • HBs levels in correlation with treatment outcome [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice

This observational study will evaluate the efficacy and safety of Pegasys (pegin terferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from p atients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.

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

Patients with chronic hepatitis B initiated on therapy 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.
 
Terminated
44
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
  • Detectable HBV DNA (as measured by PCR)
  • HBeAg positive and negative patients
  • Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
  • Elevated serum alanine aminotransferase (ALT)
  • Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation

Exclusion Criteria:

  • Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
  • Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
  • Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
  • Planned other than Pegasys antiviral treatment during Pegasys therapy
  • Chronic liver disease other than chronic hepatitis B
  • Pregnant or breast-feeding women
  • Inadequate hematologic function
  • Autoimmunology disorders
  • Co-infection with chronic hepatitis C or HIV
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01794234
ML28346
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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