An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
NCT ID: NCT01667432
Last Updated: 2017-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
141 participants
OBSERVATIONAL
2011-07-08
2014-08-12
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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Peginterferon alfa-2a
Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
* Elevated alanine aminotransferase (ALT) \> upper limit of normal (ULN) but ≤ 10 x ULN according to local label.
Exclusion Criteria
* Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
* Concomitant treatment with telbivudine.
* Pregnant or lactating women.
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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Mhat - Pleven; Clinic of Gastroenterology
Pleven, , Bulgaria
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, , Bulgaria
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, , Bulgaria
UMHAT Alexandrovska EAD; Gastroenterology
Sofia, , Bulgaria
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, , Bulgaria
Military Medical Academy; Gastroenterology
Sofia, , Bulgaria
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, , Bulgaria
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, , Bulgaria
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, , Bulgaria
Countries
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Other Identifiers
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ML25626
Identifier Type: -
Identifier Source: org_study_id
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