Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
NCT ID: NCT02106156
Last Updated: 2016-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
10228 participants
OBSERVATIONAL
2008-01-31
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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CASE_ONLY
PROSPECTIVE
Study Groups
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Chronic Hepatitis C
Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.
Pegylated interferon alfa-2a
Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
Ribavirin
Ribavirin administered according to corresponding summary of product characteristics (SmPC).
Interventions
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Pegylated interferon alfa-2a
Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
Ribavirin
Ribavirin administered according to corresponding summary of product characteristics (SmPC).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed CHC with detectable virus replication
* Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.
Exclusion Criteria
* Pregnant or breast-feeding
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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Herne, , Germany
Countries
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References
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Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014.
Other Identifiers
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ML21645
Identifier Type: -
Identifier Source: org_study_id
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