Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144469
Status:
COMPLETED
Last Update Posted:
2009-02-02
First Post:
2005-09-02
Brief Title:
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
A Phase III Study of Ro25-8310 Peginterferon Alfa-2a in Combination With Ro20-9963 Ribavirin in Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2009-01
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:
None
Brief Summary:
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection compared with peginterferon alfa-2a monotherapy
Additionally the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy
Additionally the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy
Detailed Description:
Treatment-naïve patients were randomly assigned in a 11 ratio to 48 weeks of double-blind treatment with subcutaneous once-weekly injections of 180 μg of peginterferon alfa-2a 40KD plus either twice-daily oral ribavirin 600 to 1000mgday or placebo
All patients who had received previous treatment with conventional interferon but had failed to respond no suppression of HCV-RNA below detection limits of a sensitive assay or had relapsed reversion to HCV-RNA positive state after suppression received the combination of peginterferon alfa-2a 40KD plus ribavirin for 48 weeks at the dosages stated above
All patients who had received previous treatment with conventional interferon but had failed to respond no suppression of HCV-RNA below detection limits of a sensitive assay or had relapsed reversion to HCV-RNA positive state after suppression received the combination of peginterferon alfa-2a 40KD plus ribavirin for 48 weeks at the dosages stated above
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