Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172809
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2005-09-12
Brief Title:
Interferon Treatment for Patients With Chronic Hepatitis C and End Stage Renal Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Pilot Study in Comparing the Efficacy and Safety of Peginterferon Alfa-2a and Interferon Alfa-2a in Treating Patients With End Stage Renal Disease and Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2007-06
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 treatment response with conventional interferon alpha alone in patients with end stage renal disease and chronic hepatitis C is about 33-39 However the drop-out rate is 17-296 Pegylated interferon alpha a newly developed form of interferon with superior pharmacokinetic profiles has not been used to treatment these patients We expect the better treatment response treated with peginterferon alpha than conventional interferon In addition we also observe the safety of the two drugs during the study The goal of the study is to compare the efficacy and safety of the two different treatment regimens in patients with chronic hepatitis C and end stage renal disease
Detailed Description:
Chronic hepatitis C virus HCV infection is common among patients with end stage renal disease ESRD with the reported prevalence ranging from 8 to 20 in dialysis patients in developed world In Taiwan the estimated prevalence of HCV infection in patients with ESRD who maintain hemodialysis ranges from 20 to 247 Although most studies have provided mild to moderate disease activity and a high proportion of normal alanine aminotransferase ALT levels the frequency of bridging hepatic fibrosis or cirrhosis ranges from 5 to 32 Several studies have shown that chronic hepatitis C adversely affects the survival in patients with ESRD After renal transplantation recipients with HCV have an increased risk of liver-related mortality and morbidity compared with those without HCV Therefore eradication of HCV can improve clinical outcome in dialysis patients as well as in patients awaiting renal transplantation
Combined interferon and ribavirin is the standard therapy in HCV-infected patients with normal renal function However ribavirin which is cleared by the kidneys may cause severe hemolytic anemia and be dangerous in dialysis patients Two recent meta-analyses showed that the sustained virological responses were SVR 39 and 33 the drop-out rate were 17 and 296 in HCV-infected dialysis patients treated with interferon-alpha 3 MU thrice weekly of varied duration The response and the drop-out rate were higher than that reported in HCV-infected patients with normal renal function SVR of 7-16 by interferon-alpha 3 MU thrice weekly for 24 weeks drop-out rate of 5-9 due to a lower interferon clearance rate
Peginterferon alpha-2a 40KD is a modified form of interferon alpha-2a consisting of a branched polyethylene glycol PEG chain covalently bound to interferon alpha-2a A better response of peginterferon alpha-2a than interferon alpha-2a has been demonstrated in HCV-infected patients with normal renal function either combined with ribavirin or not due to the superior pharmacokinetic profiles The clearance of peginterferon alpha-2a for ESRD patients was about 30-40 lower than that in healthy subjects A similarly pharmacokinetic profile of peginterferon alpha-2a is observed with 135 μg weekly in dialysis patients compared with 180μg weekly in patients with normal renal function
We expect that peginterferon alpha-2a is superior to interferon alpha-2a in achieving an increased SVR and decreased drop-out rate in dialysis patients The goal of the study is to compare the efficacy and safety of the two different treatment regimens in patients with chronic hepatitis C and end stage renal disease
Combined interferon and ribavirin is the standard therapy in HCV-infected patients with normal renal function However ribavirin which is cleared by the kidneys may cause severe hemolytic anemia and be dangerous in dialysis patients Two recent meta-analyses showed that the sustained virological responses were SVR 39 and 33 the drop-out rate were 17 and 296 in HCV-infected dialysis patients treated with interferon-alpha 3 MU thrice weekly of varied duration The response and the drop-out rate were higher than that reported in HCV-infected patients with normal renal function SVR of 7-16 by interferon-alpha 3 MU thrice weekly for 24 weeks drop-out rate of 5-9 due to a lower interferon clearance rate
Peginterferon alpha-2a 40KD is a modified form of interferon alpha-2a consisting of a branched polyethylene glycol PEG chain covalently bound to interferon alpha-2a A better response of peginterferon alpha-2a than interferon alpha-2a has been demonstrated in HCV-infected patients with normal renal function either combined with ribavirin or not due to the superior pharmacokinetic profiles The clearance of peginterferon alpha-2a for ESRD patients was about 30-40 lower than that in healthy subjects A similarly pharmacokinetic profile of peginterferon alpha-2a is observed with 135 μg weekly in dialysis patients compared with 180μg weekly in patients with normal renal function
We expect that peginterferon alpha-2a is superior to interferon alpha-2a in achieving an increased SVR and decreased drop-out rate in dialysis patients The goal of the study is to compare the efficacy and safety of the two different treatment regimens in patients with chronic hepatitis C and end stage renal disease
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