Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00491179
Status:
COMPLETED
Last Update Posted:
2009-11-13
First Post:
2007-06-23
Brief Title:
Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Who Fail Interferon Alfa or Pegylated Interferon Alfa Monotherapy - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-10
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:
Chronic hepatitis C virus HCV infection is common in dialysis patients Interferon IFN-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response SVR rates were 37 and 33 respectively and the corresponding dropout rates were 17 and 296 respectively The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results with a more favorable outcome of patients treated with pegylated IFN alfa-2a 135-180 μgweek SVR 33-75 well tolerated than those treated with pegylated IFN alfa-2b 05-10 μgweek SVR 125 poorly tolerated Currently IFN-based therapy to treatment HCV infection should be initiated in dialysis stages because the use of IFN in RT patients harbors high risks of acute graft rejectionand have low response rates under the concomitant use of immunosuppressive agents
Ribavirin which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia However some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin 170-300 mgday showed SVR rates of 17-66 after 24-48 weeks of treatmentIn addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50
Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN monotherapy than patients with normal renal function for HCV therapy More than half of these patients are relapsers or non-responders to IFN monotherapy Retreatment of HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to IFN monotherapy has achieved a SVR rate of 28 Based on the long-term favorable outcome in dialysis patients who eradicate HCV the aim of the study is to evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or pegylated IFN alfa
Ribavirin which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia However some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin 170-300 mgday showed SVR rates of 17-66 after 24-48 weeks of treatmentIn addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50
Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN monotherapy than patients with normal renal function for HCV therapy More than half of these patients are relapsers or non-responders to IFN monotherapy Retreatment of HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to IFN monotherapy has achieved a SVR rate of 28 Based on the long-term favorable outcome in dialysis patients who eradicate HCV the aim of the study is to evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or pegylated IFN alfa
Detailed Description:
Chronic hepatitis C virus HCV infection is common in dialysis patients with the reported prevalence varying from 3 to 80 worldwide1-3 Although these patients usually have mild symptoms and moderate elevation of alanine transaminase levels recent international collaborative survey and prospective studies found that anti-HCV seropositivity and positive HCV RNA were risk factors for mortality and hepatocellular carcinoma HCC4-7 Furthermore progressive hepatic fibrosis poor patient and graft survival were observer in dialysis patients with HCV infection who undergo renal transplantation RT suggesting immunosuppression following RT may worsen the course of hepatic fibrosis and renal graft function8-13 These lines of evidence indicate that HCV infection in the dialysis population is an important issue to be tackled
Interferon IFN-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients In dialysis patients treatment with conventional or pegylated interferon has also received much attention recently Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response SVR rates were 37 and 33 respectively and the corresponding dropout rates were 17 and 296 respectively1415 The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results with a more favorable outcome of patients treated with pegylated IFN alfa-2a 135-180 μgweek SVR 33-75 well tolerated than those treated with pegylated IFN alfa-2b 05-10 μgweek SVR 125 poorly tolerated16-21 which may result from different pharmacokinetic profiles between these two pegylated IFNs Currently IFN-based therapy to treatment HCV infection should be initiated in dialysis stages because the use of IFN in RT patients harbors high risks of acute graft rejection2223 and have low response rates under the concomitant use of immunosuppressive agents2425 Ribavirin which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia However some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin 170-300 mgday showed SVR rates of 17-66 after 24-48 weeks of treatment26-28 In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 5029 Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN monotherapy than patients with normal renal function for HCV therapy More than half of these patients are relapsers or non-responders to IFN monotherapy Retreatment of HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to IFN monotherapy has achieved a SVR rate of 2830 Based on the long-term favorable outcome in dialysis patients who eradicate HCV the aim of the study is to evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or pegylated IFN alfa
Interferon IFN-based treatment for chronic hepatitis C has been the mainstay therapy in immunocompetent patients In dialysis patients treatment with conventional or pegylated interferon has also received much attention recently Two meta-analyses evaluating the efficacy and safety of conventional IFN alfa monotherapy showed that the sustained virologic response SVR rates were 37 and 33 respectively and the corresponding dropout rates were 17 and 296 respectively1415 The efficacy and safety of pegylated IFN alfa-2a and 2b in treating dialysis patients showed conflicting results with a more favorable outcome of patients treated with pegylated IFN alfa-2a 135-180 μgweek SVR 33-75 well tolerated than those treated with pegylated IFN alfa-2b 05-10 μgweek SVR 125 poorly tolerated16-21 which may result from different pharmacokinetic profiles between these two pegylated IFNs Currently IFN-based therapy to treatment HCV infection should be initiated in dialysis stages because the use of IFN in RT patients harbors high risks of acute graft rejection2223 and have low response rates under the concomitant use of immunosuppressive agents2425 Ribavirin which has been used in combination with IFN to treat chronic hepatitis C in the general patients and achieve a higher SVR rate than IFN monotherapy is considered contraindicated in dialysis patients with chronic hepatitis C due to the risk of severe hemolytic anemia However some pilot studies evaluating combined conventional IFN alfa plus low dose ribavirin 170-300 mgday showed SVR rates of 17-66 after 24-48 weeks of treatment26-28 In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 5029 Although dialysis patients have a higher SVR rate to conventional IFN or pegylated IFN monotherapy than patients with normal renal function for HCV therapy More than half of these patients are relapsers or non-responders to IFN monotherapy Retreatment of HCV-patients with normal renal function by combined pegylated IFN alfa plus ribavirin who fail to response to IFN monotherapy has achieved a SVR rate of 2830 Based on the long-term favorable outcome in dialysis patients who eradicate HCV the aim of the study is to evaluate the efficacy and safety of retreatment by pegylated IFN alfa-2a plus low dose ribavirin in dialysis patients who fail to achieve HCV eradication by conventional or pegylated IFN alfa
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