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

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. Identifier: NCT01794234
Recruitment Status : Terminated
First Posted : February 18, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients 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.

Condition or disease
Hepatitis B, Chronic

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : August 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. HBs levels in correlation with treatment outcome [ Time Frame: approximately 2.5 years ]
  2. 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 ]
  3. For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization [ Time Frame: approximately 2.5 years ]
  4. Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis B initiated on therapy with Pegasys

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

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 identifier (NCT number): NCT01794234

Bytom, Poland, 41-902
Debica, Poland, 39-200
Gdansk, Poland, 80-214
Krakow, Poland, 31-202
Krakow, Poland, 31-501
Lancut, Poland, 37-100
Myslowice, Poland, 41-400
Raciborz, Poland, 47-400
Wroclaw, Poland, 51-149
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01794234     History of Changes
Other Study ID Numbers: ML28346
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs