Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00491244
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2007-06-23
Brief Title:
Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Versus Pegylated Interferon Alfa-2a Alone for Treatment-naïve Hemodialysis Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2014-01
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 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 respectivelyThe 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 treatment In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50 In this study treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin 100 vs 25
Based on the long-term favorable outcome in dialysis patients who eradicate HCV and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with chronic hepatitis C
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 treatment In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50 In this study treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin 100 vs 25
Based on the long-term favorable outcome in dialysis patients who eradicate HCV and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a alone in treatment naïve dialysis patients with chronic hepatitis C
Detailed Description:
Chronic hepatitis C virus HCV infection is common in dialysis patients with the reported prevalence varying from 3 to 80 worldwide 1-3 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 HCC 4-7 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 function 8-13 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 tolerated 16-21 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 agents 2425 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 treatment 26-28 In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50 29 In this study treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin 100 vs 25 Based on the long-term favorable outcome in dialysis patients who eradicate HCV and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a in treatment naïve dialysis patients with chronic hepatitis C
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 tolerated 16-21 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 agents 2425 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 treatment 26-28 In addition a recent study including 6 patients with combination of pegylated IFN alfa plus low dose ribavirin also showed a SVR rate of 50 29 In this study treatment with pegylated IFN alfa-2a plus low dose ribavirin achieved a higher SVR rate that that with pegylated IFN alfa-2b plus low dose ribavirin 100 vs 25 Based on the long-term favorable outcome in dialysis patients who eradicate HCV and the superior response of pegylated IFN alfa-2a plus low dose ribavirin to pegylated IFN alfa-2b plus low dose ribavirin in treating dialysis patients with chronic hepatitis C the aim of the study is to evaluate the efficacy and safety of pegylated IFN alfa-2a plus low dose ribavirin versus pegylated interferon alfa-2a in treatment naïve dialysis patients with chronic hepatitis C
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