Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495131
Status:
COMPLETED
Last Update Posted:
2009-09-10
First Post:
2007-06-29
Brief Title:
Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Genotype 1-infected Patients in Taiwan
Status:
COMPLETED
Status Verified Date:
2009-09
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 prevalent in the world affecting 3 of the worlds population The current standard of therapy is pegylated interferon and ribavirin reaching 54-63 of successful rates In patients with HCV genotype 1 infection a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy However several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries Therefore whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear
Detailed Description:
Combination therapy with interferon alfa IFN-α plus ribavirin for 24 to 48 weeks produces sustained virologic response SVR rate in approximately 31-47 of treatment naïve patients with chronic hepatitis C1-5 Patients with genotype 1 virus infection are less likely to have SVR that those with other genotypes infection and therefore patients infected with hepatitis C virus HCV genotype 1 should receive treatment for 48 weeks6 Recently combination therapy with pegylated interferon alfa pegylated IFN-α plus ribavirin produces higher SVR rates 54-56 than that with IFN-α plus ribavirin78 Furthermore a large trial assessing the effect and duration of pegylated IFN-α plus ribavirin showed that the overall SVR rate was 63 Among patients with genotype 1 HCV infection standard dose ribavirin 1000 to 1200 mg per day and 48 weeks of treatment were significantly more effective than low dose ribavirin 800 mg per day or 24 weeks of treatment9 The SVR rate was 51 for genotype 1 patients receiving pegylated IFN-α plus standard dose ribavirin for 48 weeks whereas only 29 and 41 for those receiving pegylated IFN-α plus low dose ribavirin and standard dose ribavirin for 24 weeks respectively Based on these lines of evidence 48 weeks of therapy with pegylated IFN-α pegylated IFN-α 2a 180 μg or pegylated IFN-α 2b 15 μg per kilogram body weight weekly plus ribavirin 1000 to 1200 mg per day is recommended to treat patients with HCV genotype 1 infection10 In Taiwan a multicenter study showed that a 6 month course treatment with pegylated IFN-α plus standard dose ribavirin had a comparable SVR rate to that with IFN-α plus standard dose ribavirin 671 versus 636 in patients with chronic hepatitis C Subgroup analysis showed that treatment with pegylated IFN-α plus standard dose ribavirin had a significantly higher SVR rate to that with IFN-α plus standard dose ribavirin 658 versus 410 in patients with genotype 1 HCV infection11 Recently a pilot study comparing 24 and 48 weeks of pegylated IFN-α plus standard dose ribavirin in patients with genotype 1 HCV infection showed that 48 weeks of treatment is more efficacious that 24 weeks of treatment SVR rate 800 versus 48912 However much difference of SVR rates occurred in these two studies making optimal therapy in Taiwanese patients infected with genotype 1 HCV difficult to be determined In the study we aim to investigate in a large cohort whether 48 weeks treatment with pegylated IFN-α plus standard dose ribavirin is more efficacious than 24 weeks treatment in patients with genotype 1 HCV infection
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