Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262379
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2005-12-05
Brief Title:
Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Multicenter Study Randomized and Pragmatic Comparing Two Therapeutic Strategies Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin
Status:
COMPLETED
Status Verified Date:
2014-12
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:
The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin
Detailed Description:
Show that the correction of anemia by epoetin beta NeoRecormon able to maintain a optimal dose of ribavirin Copegus The study compares two therapeutic strategies use or non-use of epoetin beta NeoRecormon in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a Pegasys plus ribavirin Copegus The main judgement criteria are
Sustained Viral Response Week 72
Viral Response at the End of Treatment Week 48
Quality of life
Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
Clinical and biological tolerance
Sustained Viral Response Week 72
Viral Response at the End of Treatment Week 48
Quality of life
Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
Clinical and biological tolerance
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