Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483938
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2007-06-07
Brief Title:
The Individualized Management With Pegylated-interferon Alfa-2a Pegasys and Ribavirin Copegus Offering Viral Eradication A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C CHC Non-genotype 23 IMPROVE
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication IMPROVE Trial
Status:
COMPLETED
Status Verified Date:
2016-11
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:
IMPROVE
Brief Summary:
This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 23 CHC who after 12 weeks of study treatment have undetectable hepatitis C virus HCV-ribonucleic acid RNA or a greater than or equal to 2 log10 drop in HCV-RNA Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin 1000-1400 milligram mg orally daily for the specified duration followed by 24 weeks of treatment-free follow-up Participants with detectable HCV-RNA and less than 2 log10 drop in HCV-RNA at week 12 will discontinue therapy
Detailed Description:
None
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