Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209118
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2005-09-14
Brief Title:
Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Paroxetine for the Prevention of IFN-Alpha Associated Depression in Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2016-04
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:
AOVERVIEW
This is a 26 week study examining the ability of paroxetine Paxil to prevent the development of depression and neurotoxicity in patients receiving either 3 million units of subcutaneous IFNinterferon-alpha-2b 3 timesweek plus ribavirin 1000-1200 mgd or PEG polyethylene glycol interferon-alpha-2b 15 microgramskg one time a week and ribavirin 800 to 1400 mg a day for chronic hepatitis C CHC The IFN plasma half life t12 of 24 to 34 hours of PEG a CHC treatment recently approved by the FDA is significantly prolonged allowing for once a week dosing Studies indicate that the side effect profile of the two forms of IFN-alpha treatment are very similar CHC patients will be screened for study eligibility and a total of 100 CHC patients between the ages of 18 and 65 years old will be enrolled across three sites 30 at Emory site and a combination of 30 from the University of Pennsylvania Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical Center in New York Two weeks prior to treatment with subcutaneous IFN-alpha-2b patients who meet inclusion and exclusion criteria will be stratified on the basis of a history of major depression and then randomly assigned to paroxetine or placebo in double blind fashion
This is a 26 week study examining the ability of paroxetine Paxil to prevent the development of depression and neurotoxicity in patients receiving either 3 million units of subcutaneous IFNinterferon-alpha-2b 3 timesweek plus ribavirin 1000-1200 mgd or PEG polyethylene glycol interferon-alpha-2b 15 microgramskg one time a week and ribavirin 800 to 1400 mg a day for chronic hepatitis C CHC The IFN plasma half life t12 of 24 to 34 hours of PEG a CHC treatment recently approved by the FDA is significantly prolonged allowing for once a week dosing Studies indicate that the side effect profile of the two forms of IFN-alpha treatment are very similar CHC patients will be screened for study eligibility and a total of 100 CHC patients between the ages of 18 and 65 years old will be enrolled across three sites 30 at Emory site and a combination of 30 from the University of Pennsylvania Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical Center in New York Two weeks prior to treatment with subcutaneous IFN-alpha-2b patients who meet inclusion and exclusion criteria will be stratified on the basis of a history of major depression and then randomly assigned to paroxetine or placebo in double blind fashion
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