An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
NCT ID: NCT02557646
Last Updated: 2016-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
697 participants
OBSERVATIONAL
2009-05-31
2014-03-31
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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Pegasys + Copegus
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
Peginterferon alfa-2a
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
Ribavirin
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
Interventions
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Peginterferon alfa-2a
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
Ribavirin
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants using and accepting a double method of contraception
Exclusion Criteria
* Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
* Participants previously treated with pegylated interferon and/or ribavirin
* Hepatitis B and Human Immunodeficiency Virus co-infections
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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Ajka, , Hungary
Balassagyarmat, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Debrecen, , Hungary
Győr, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Pécs, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Tatabánya, , Hungary
Zalaegerszeg, , Hungary
Countries
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Other Identifiers
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ML22453
Identifier Type: -
Identifier Source: org_study_id
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