Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00277862
Status:
COMPLETED
Last Update Posted:
2008-02-26
First Post:
2006-01-15
Brief Title:
Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2bRibavirin in Chronic Hepatitis C Genotype 4
Status:
COMPLETED
Status Verified Date:
2008-02
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:
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70 The duration of treatment has not been accurately defined The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C
Detailed Description:
Hepatitis C virus HCV genotype 4 is the most frequent cause of chronic hepatitis C in Middle East North Africa and sub-Saharan Africa In countries like Egypt 73 to 90 of cases of chronic hepatitis C are caused by genotype 4 Recently epidemiological reports showed spread of HCV-4 infection in Western countries such as France Italy Greece Spain and the United States particularly among intravenous drug users
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70 We have previously shown that treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or 48 weeks was more effective SVR 66 and 69 respectively than for 24 weeks
It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who achieve an early virologic have a higher chance to achieve a sustained virologic response Peg interferon and ribavirin therapy is associated with adverse events and is expensive therefore careful determination of the optimal treatment duration is crucial as it spares the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy
Therefore the main objective of this randomized multicenter trial is to assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70 We have previously shown that treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or 48 weeks was more effective SVR 66 and 69 respectively than for 24 weeks
It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who achieve an early virologic have a higher chance to achieve a sustained virologic response Peg interferon and ribavirin therapy is associated with adverse events and is expensive therefore careful determination of the optimal treatment duration is crucial as it spares the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy
Therefore the main objective of this randomized multicenter trial is to assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in 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