An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
NCT ID: NCT01750216
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
196 participants
OBSERVATIONAL
2012-07-31
2015-01-31
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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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C genotype 1
* Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
* Confirmed serum positive HCV RNA
* Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment
Exclusion Criteria
* Co-infection with hepatitis B or HIV
* Post-transplant patients
* End stage renal disease (creatinine clearance \< 15 ml/min)
* Patients treated with immunotherapy
* Pregnant women and male partners of women who are pregnant
* Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
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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Bydgoszcz, , Poland
Bytom, , Poland
Chorzów, , Poland
Ciechanów, , Poland
Dębica, , Poland
Katowice, , Poland
Koszalin, , Poland
Lodz, , Poland
Mielec, , Poland
Puławy, , Poland
Radom, , Poland
Warsaw, , Poland
Wałbrzych, , Poland
Łańcut, , Poland
Countries
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Other Identifiers
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ML28344
Identifier Type: -
Identifier Source: org_study_id