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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724451
• Other study ID #: P05488
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 24, 2015
• Start date: July 2008
• Est. completion date: October 2011

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• Peginterferon alfa-2b
Peginterferon alfa-2b administered in accordance with approved labeling

Drug:
• Ribavirin
Ribavirin administered in accordance with approved labeling

Biological:
• Peginterferon alfa-2a
Peginterferon alfa-2a administered in accordance with approved labeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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	No