Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with chronic hepatitis B initiated on therapy with Pegasys

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794234

Locations
Poland
Bytom, Poland, 41-902
Debica, Poland, 39-200
Gdansk, Poland, 80-214
Krakow, Poland, 31-202
Krakow, Poland, 30-501
Lancut, Poland, 37-100
Myslowice, Poland, 41-400
Raciborz, Poland, 47-400
Wroclaw, Poland, 51-149
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01794234     History of Changes
Other Study ID Numbers: ML28346
Study First Received: February 15, 2013
Last Updated: November 3, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014