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

September 24, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • Copegus
  • Rebetol
  • RBV
  • SCH 018908
  • Virazole
Biological: Peginterferon alfa-2a
Peginterferon alfa-2a administered in accordance with approved labeling
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks after the end of treatment (total of 48 to 72 weeks)
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.
24 to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Peginterferon alfa-2b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe