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

NCT00724451 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1128

Last updated 2015-09-25

Study results available
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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.

Conditions

  • Hepatitis C
  • Hepatitis C, Chronic

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00724451 on ClinicalTrials.gov