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NCT Number: NCT00724451

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2b

Biological

Peginterferon alfa-2b administered in accordance with approved labeling

Other names: SCH 054031, PegIntron

Ribavirin

Drug

Ribavirin administered in accordance with approved labeling

Other names: SCH 018908, Copegus, Rebetol, Virazole, RBV

peginterferon alfa-2a

Biological

Peginterferon alfa-2a administered in accordance with approved labeling

Other names: Pegasys

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 29, 2008
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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