Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512278
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2007-08-03
Brief Title:
Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C
Sponsor:
Nizar Zein
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Infliximab Remicade as an Adjunct to Pegylated- Interferon α-2b and Ribavirin in the Treatment of Hepatitis C Virus Infection
Status:
COMPLETED
Status Verified Date:
2017-08
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:
PARTNER
Brief Summary:
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection
Detailed Description:
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection genotype 1 whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin
increases the proportion of subjects attaining a sustained virological response SVR undetectable blood Hepatitis C viral load 6 months after treatment
improves the safety profile compared to the same regimen without infliximab
increases the proportion of subjects attaining a sustained virological response SVR undetectable blood Hepatitis C viral load 6 months after treatment
improves the safety profile compared to the same regimen without infliximab
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