N/A
N=1,128
Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
Hepatitis C · Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00724451 ↗Enrolled (actual)
1,128
Serious AEs
1.2%
Results posted
Oct 2012
Primary outcome: Primary: Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility — 144; 77; 17; 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peginterferon alfa-2b (Biological); Ribavirin (Drug); Peginterferon alfa-2a (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility |
144; 77; 17; 7; 2; 139 | — |
| SECONDARY Number of Participants Discontinued From Treatment by Reason for Discontinuation |
3; 27; 44; 32; 5; 22 | — |
| SECONDARY Number of Participants With Treatment Failure by Reason for Failure |
71; 61 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00724451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.