A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
NCT ID: NCT02570191
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2004-11-30
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peginterferon alfa-2a
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter \[mL\] solution) once a week subcutaneously for 48 weeks.
Peginterferon alfa-2a
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Interventions
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Peginterferon alfa-2a
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive test result for HBsAg for \>6 months
* Naive to treatment for HBV
* On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
Exclusion Criteria
* Decompensated liver disease
* Hepatocellular cancer
* Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
* Medical condition associated with chronic liver disease
18 Years
70 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_CHAIR
Hoffmann-La Roche
Locations
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Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Countries
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Other Identifiers
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ML18092
Identifier Type: -
Identifier Source: org_study_id