Viewing Study NCT01342003



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Last Modification Date: 2024-10-26 @ 10:34 AM
Study NCT ID: NCT01342003
Status: COMPLETED
Last Update Posted: 2011-04-26
First Post: 2011-04-25

Brief Title: HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b
Sponsor: Azienda Ospedaliera San Camillo Forlanini
Organization: Azienda Ospedaliera San Camillo Forlanini

Study Overview

Official Title: HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b
Status: COMPLETED
Status Verified Date: 2010-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: genotype
Brief Summary: Sustained virological response SVR to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype 1a vs1b has not been extensively investigated This observational study was carried out on a large group of naïve HCV patients to evaluate difference if any between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon Peg-IFN plus ribavirin
Detailed Description: Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C viral replication such as protease and polymerase inhibitors nowadays the standard treatment in genotype 1-chronic hepatitis C CHC is the combination of peghylated interferon PEG-IFN and ribavirin for 48 weeks It has been extensively shown that patients infected with HCV genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3 In large randomized multinational trials sustained virological response SVR of around 50 has been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup of patients infected with HCV genotype 1 Furthermore advanced fibrosis is a predictive factor of non response to antiviral treatment in genotype 1 virus 5-7 Very few studies have evaluated SVR difference if any between subtypes 1a and 1b

We have carried out an observational study on a large cohort of HCV naïve patients to evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus ribavirin

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None