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

Study Overview
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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.

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.

Official Title
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Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice

Conditions
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Hepatitis C, Hepatitis C, Chronic

Intervention / Treatment
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* Biological: Peginterferon alfa-2b
* Drug: Ribavirin
* Biological: Peginterferon alfa-2a


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Chronic Hepatitis C (CHC)<br>Peginterferon-naïve participants with CHC seen in general clinical practice in Italy and treated with either pegylated interferon alfa-2a or alfa-2b + ribavirin. | Biological: Peginterferon alfa-2b<br>* Peginterferon alfa-2b administered in accordance with approved labeling<br>* Other names: PegIntron;Drug: Ribavirin<br>* Ribavirin administered in accordance with approved labeling<br>* Other names: RBV;Biological: Peginterferon alfa-2a<br>* Peginterferon alfa-2a administered in accordance with approved labeling<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. | Measured at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Discontinued From Treatment by Reason for Discontinuation | Investigators recorded reasons for treatment discontinuation. | 24 weeks after the end of treatment (total of 48 to 72 weeks) | 
| Number of Participants With Treatment Failure by Reason for Failure | Investigators recorded reasons for treatment failure whether or not treatment was completed. | 24 to 48 weeks |