Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370617
Status:
UNKNOWN
Last Update Posted:
2006-11-14
First Post:
2006-08-30
Brief Title:
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
An Efficacy and Safety Study Comparing Pegylated-Interferon and Ribavirin Plus Metformin to Pegylated-Interferon and Ribavirin in the Treatment of naïve Patients With Genotype 1 Chronic HCV Infection and Insulin Resistance
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
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:
Chronic hepatitis C virus HCV infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance irrespective of the severity of liver disease
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C
In an in vitro model increased levels of insulin may promote increased HCV replication
RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C
In an in vitro model increased levels of insulin may promote increased HCV replication
RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication
Detailed Description:
Chronic hepatitis C virus HCV infection is associated with an increased risk for the development of type 2 diabetes and HCV infection itself may promote insulin resistance irrespective of the severity of liver disease
In patients with HCV infection an increase in fasting insulin levels is associated with the presence of serum HCV core the severity of hepatic fibrosis and a decrease in expression of insulin receptor substrate IRS 1 and IRS2 central molecules of the insulin-signaling cascade Down-regulation of IRS1 and IRS2 has also been observed in HCV core-transgenic mice livers and HCV core-transfected human hepatoma cells
High levels of tumor necrosis factor-alpha which acts by disturbing tyrosine phosphorylation of insulin receptor substrate-1 may be associated with insulin resistance both in animal models and in HCV patients
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C
In patients infected with genotype non-3 insulin resistance is associated with the degree of fibrosis the rate of fibrosis progression and previous failed antiviral treatment
Insulin resistance fibrosis and genotype are independent predictors of the response to antiviral therapy in chronic hepatitis C patients treated with peginterferon plus ribavirin A sustained virological response is achieved in 33 of patients with genotype 1 and insulin resistance compared with 60 of genotype 1 patients without insulin resistance
Insulin resistance is associated with a 3-fold risk of failure to antiviral treatment in patients with genotype 1 In an in vitro model increased levels of insulin may promote increased HCV replication
RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication
INDICATION Genotype 1 Chronic HCV hepatitis CHC associated with insulin resistance IR
OBJECTIVES To compare the efficacy and safety of Pegylated-Interferon and Ribavirin plus metformin to Pegylated-Interferon and Ribavirin for treatment of naïve patients with Genotype 1 Chronic HCV infection and insulin resistance
In patients with HCV infection an increase in fasting insulin levels is associated with the presence of serum HCV core the severity of hepatic fibrosis and a decrease in expression of insulin receptor substrate IRS 1 and IRS2 central molecules of the insulin-signaling cascade Down-regulation of IRS1 and IRS2 has also been observed in HCV core-transgenic mice livers and HCV core-transfected human hepatoma cells
High levels of tumor necrosis factor-alpha which acts by disturbing tyrosine phosphorylation of insulin receptor substrate-1 may be associated with insulin resistance both in animal models and in HCV patients
Insulin resistance seems to be genotype specific and may play a role in fibrogenesis in chronic hepatitis C
In patients infected with genotype non-3 insulin resistance is associated with the degree of fibrosis the rate of fibrosis progression and previous failed antiviral treatment
Insulin resistance fibrosis and genotype are independent predictors of the response to antiviral therapy in chronic hepatitis C patients treated with peginterferon plus ribavirin A sustained virological response is achieved in 33 of patients with genotype 1 and insulin resistance compared with 60 of genotype 1 patients without insulin resistance
Insulin resistance is associated with a 3-fold risk of failure to antiviral treatment in patients with genotype 1 In an in vitro model increased levels of insulin may promote increased HCV replication
RATIONALE Decreased insulin resistance and reduced hyperinsulinemia may facilitate the efficacy of anti-viral drugs on HCV replication
INDICATION Genotype 1 Chronic HCV hepatitis CHC associated with insulin resistance IR
OBJECTIVES To compare the efficacy and safety of Pegylated-Interferon and Ribavirin plus metformin to Pegylated-Interferon and Ribavirin for treatment of naïve patients with Genotype 1 Chronic HCV infection and insulin resistance
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