Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-10-31

Brief Summary

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The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.

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Detailed Description

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Probability sampling: Consecutive adult patients with chronic hepatitis C in clinical practice at approximately 54 sites in Italy will be included in the study. The decision as to treatment choice falls at the discretion of the treating physician.

Conditions

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Hepatitis C Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Chronic Hepatitis C (CHC)

Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin.

Peginterferon alfa-2b

Intervention Type BIOLOGICAL

Peginterferon alfa-2b administered in accordance with approved labeling

Ribavirin

Intervention Type DRUG

Ribavirin administered in accordance with approved labeling

Peginterferon alfa-2a

Intervention Type BIOLOGICAL

Peginterferon alfa-2a administered in accordance with approved labeling

Interventions

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Peginterferon alfa-2b

Peginterferon alfa-2b administered in accordance with approved labeling

Intervention Type BIOLOGICAL

Ribavirin

Ribavirin administered in accordance with approved labeling

Intervention Type DRUG

Peginterferon alfa-2a

Peginterferon alfa-2a administered in accordance with approved labeling

Intervention Type BIOLOGICAL

Other Intervention Names

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SCH 054031 PegIntron SCH 018908 Copegus Rebetol Virazole RBV Pegasys

Eligibility Criteria

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Inclusion Criteria

* Willingness to sign an Informed Consent
* Male and female patients \>=18 years of age with Chronic Hepatitis C
* Not previously treated with Peg-Interferons
* Positive for serum hepatitis C virus (HCV)-ribonucleic acid (RNA)

Exclusion Criteria

* Previous treatment with peginterferon
* Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No