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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00724451
First received: July 25, 2008
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Hepatitis C
Hepatitis C, Chronic
 Biological: Peginterferon alfa-2b
Drug: Ribavirin
Biological: Peginterferon alfa-2a

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Observational, Multicentre Study Evaluating HCV Patients Characteristics of Eligibility and Disease Management in Real Clinical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Investigators recorded reasons for treatment discontinuation.

  • Number of Participants With Treatment Failure by Reason for Failure [ Time Frame: 24 to 48 weeks ] [ Designated as safety issue: No ]
    Investigators recorded reasons for treatment failure whether or not treatment was completed.


Enrollment: 1128
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • SCH 054031
  • PegIntron
Drug: Ribavirin
Ribavirin administered in accordance with approved labeling
Other Names:
  • SCH 018908
  • Copegus
  • Rebetol
  • Virazole
  • RBV
Biological: Peginterferon alfa-2a
Peginterferon alfa-2a administered in accordance with approved labeling
Other Name: Pegasys

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00724451     History of Changes
Other Study ID Numbers: P05488
Study First Received: July 25, 2008
Results First Received: October 5, 2012
Last Updated: November 16, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013