Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice
1 other identifier
observational
1,128
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2008
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
October 31, 2012
CompletedSeptember 25, 2015
September 1, 2015
3.3 years
July 25, 2008
October 5, 2012
September 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants Discontinued From Treatment by Reason for Discontinuation
24 weeks after the end of treatment (total of 48 to 72 weeks)
Number of Participants With Treatment Failure by Reason for Failure
24 to 48 weeks
Study Arms (1)
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.
Interventions
Peginterferon alfa-2b administered in accordance with approved labeling
Ribavirin administered in accordance with approved labeling
Peginterferon alfa-2a administered in accordance with approved labeling
Eligibility Criteria
Consecutive adult patients with chronic hepatitis C seen in common clinical practice at approximately 54 sites in Italy. Treatment for hepatitis C is determined at the local site (pegylated interferon a or b/ribavirin).
You may qualify if:
- 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)
You may not qualify if:
- Previous treatment with peginterferon
- Participation in a therapeutic Good Clinical Practice (GCP) clinical study within 30 days prior to study start
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Vukotic R, Gamal N, Andreone P. Prospective, observational real-life study on eligibility for and outcomes of antiviral treatment with peginterferon alpha plus ribavirin in chronic hepatitis C. Dig Liver Dis. 2015 Feb;47(2):151-6. doi: 10.1016/j.dld.2014.11.002. Epub 2014 Nov 13.
PMID: 25483909DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 25, 2015
Results First Posted
October 31, 2012
Record last verified: 2015-09