A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-07-31

Brief Summary

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In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Peginterferon alfa-2a + Ribavirin

Peginterferon alfa-2a

Intervention Type DRUG

Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Ribavirin

Intervention Type DRUG

Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Interventions

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Peginterferon alfa-2a

Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Intervention Type DRUG

Ribavirin

Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

* Male and female patients \>/= 18 years
* Positive test for HCV
* Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion Criteria

* Concomitant infection with HIV or hepatitis B
* Participation in a clinical trial within 30 days prior to study start
* Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No