Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272389
Status:
UNKNOWN
Last Update Posted:
2006-01-06
First Post:
2006-01-04
Brief Title:
Prediction of Response to Treatment of Patients With Chronic HCV Infection by Genetic Profile
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Prediction of Response to PEGINTERFERON and RIBAVIRIN Treatment in Patients With Chronic HCV Infection by Genetic Profile
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
NOT_YET_RECRUITING
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:
We hypothesized that pretreatment nonresponder and responder liver tissue would show consistent differences in gene expression levels and that these differences could be used to predict treatment outcomes and this can obviate the need of the present therapeutic trialWe are interested in conducting a retrospective study using the data of patients suffering from chronic HCV infection who were treated in our department with a combination of PEGINTERFERON and RIBAVIRIN All these patients underwent liver biopsy prior the treatment Based on the clinical data available it is possible to determine the responders and nonresponders to this therapyRNA will be extracted from the liver tissue and the expression of 5 genesIFI15IFI616IFI1OAS3OAS2 will be checked The prediction power of the combination of these genes in differentiating responders from nonresponders will be determined
Detailed Description:
Hepatitis C virus is a leading cause of chronic liver disease with over 170 million people infected worldwide It is also the leading indication for liver transplantation Complications from chronic hepatitis C infection include cirrhosis hepatic decompensation and hepatocellular carcinoma As a result treatment strategies to prevent such complications have been widely researched although many questions remain unanswered To date the standard therapy for chronic hepatitis C infection is the combination of peginterferon and ribavirinA large proportion of patients do not respond to therapy for reasons that are unclear The heterogeneity of viral and host phenotypes makes it unlikely that any single factor will accurately predict the cellular response to treatmentIt was supposed that liver tissue of nonresponder and responder show consistent differences in gene expression levels and that these differences could be used to predict treatment outcomesHepatic gene expression profiling identified consistent differences in patients who subsequently fail treatment with pegylated IFN-α plus ribavirin up-regulation of a specific set of IFN-responsive genes predicts nonresponse to exogenous therapy These data may be of use in predicting clinical responses to treatment 18 genes confirmed by real-time PCR with expression levels that differed consistently between nonresponders and responders liver tissue were detected Levels for these 18 genes in responders liver were closer to uninfected tissue than to nonresponders liver with a general up-regulation of gene expression in nonresponders liver Many of these genes are IFN responsive suggesting that the nonresponders patients have adopted a different yet characteristic equilibrium in their host-virus immune responseChen L et al Gastroentology 20051281437-1444 We have found a method that can predict success or failure of the treatment of chronic hepatitis C based on the weighted expression level of a small number of genes 4-5 We derive the genes and their decision weights from the microarray data set obtained from the liver biopsy of the patients in the above mentioned paper We would like to test the prediction power of this method in an independent set of liver tissues of treated patients in our department
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