An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
NCT ID: NCT01794234
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
44 participants
OBSERVATIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bytom, , Poland
Dębica, , Poland
Gdansk, , Poland
Krakow, , Poland
Krakow, , Poland
Mysłowice, , Poland
Racibórz, , Poland
Wroclaw, , Poland
Łańcut, , Poland
Countries
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Other Identifiers
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ML28346
Identifier Type: -
Identifier Source: org_study_id