Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
|ClinicalTrials.gov Identifier: NCT00724451|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : October 31, 2012
Last Update Posted : September 25, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment|
|Hepatitis C Hepatitis C, Chronic||Biological: Peginterferon alfa-2b Drug: Ribavirin Biological: Peginterferon alfa-2a|
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.
|Study Type :||Observational|
|Actual Enrollment :||1128 participants|
|Official Title:||Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice|
|Study Start Date :||July 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
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.
Biological: Peginterferon alfa-2b
Peginterferon alfa-2b administered in accordance with approved labeling
Other Names:Drug: Ribavirin
Ribavirin administered in accordance with approved labeling
Other Names:Biological: Peginterferon alfa-2a
Peginterferon alfa-2a administered in accordance with approved labeling
Other Name: Pegasys
Primary Outcome Measures :
- Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility [ Time Frame: Measured at baseline ]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.
Secondary Outcome Measures :
- Number of Participants Discontinued From Treatment by Reason for Discontinuation [ Time Frame: 24 weeks after the end of treatment (total of 48 to 72 weeks) ]Investigators recorded reasons for treatment discontinuation.
- Number of Participants With Treatment Failure by Reason for Failure [ Time Frame: 24 to 48 weeks ]Investigators recorded reasons for treatment failure whether or not treatment was completed.
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