Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01025765
Status:
UNKNOWN
Last Update Posted:
2012-11-27
First Post:
2009-12-02
Brief Title:
The Effects of Oral Hypoglycemic Agents on Chronic Hepatitis C Patients Receiving Peg-Intron Plus Ribavirin
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
An Open-label Multi-center Randomized Study Comparing the Effects of Oral Hypoglycemic Agents on Viral Kinetics of Chronic Hepatitis C Patients Receiving Pegylated Interferon Alfa 2b Plus Ribavirin
Status:
UNKNOWN
Status Verified Date:
2012-11
Last Known Status:
ACTIVE_NOT_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:
Pegylated interferon in combination with ribavirin is the current standard treatment of chronic hepatitis C virus infection but is expensive and has several adverse effects To modify this standard treatment by optimizing its therapeutic effect and decreasing its adverse events are important Recent studies have identified a close link between metabolic profiles insulin resistance and Hepatitis C Virus HCV infection Several pilot studies in western world have have found beneficial effects of oral hypoglycemic agents on chronic Hepatitis C CHC genotype 1 infected patients Whether this concept still holds true in Taiwanese people remains unknown
The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents daily for 4 weeks of run-in period and 8 weeks of combination treatment on CHC genotype 1 infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin RBA and the enrolled subjects will be randomized into 4 treatment groups including Acarbose Metformin Pioglitazone and standard care control groups During the trial and 24 weeks after the end of treatment serial serum HCV RNA alanine aminotransferase ALT levels and other clinical data will be evaluated to determine the therapeutic response and adverse events of the CHC patients
The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents daily for 4 weeks of run-in period and 8 weeks of combination treatment on CHC genotype 1 infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin RBA and the enrolled subjects will be randomized into 4 treatment groups including Acarbose Metformin Pioglitazone and standard care control groups During the trial and 24 weeks after the end of treatment serial serum HCV RNA alanine aminotransferase ALT levels and other clinical data will be evaluated to determine the therapeutic response and adverse events of the CHC patients
Detailed Description:
Pegylated interferon in combination with ribavirin is the current standard treatment of chronic hepatitis C virus infection but is expensive and has several adverse effects To modify this standard treatment by optimizing its therapeutic effect and decreasing its adverse events are important
Recent studies have identified a close link between metabolic profiles insulin resistance and HCV infection Chronic hepatitis C CHC patients with higher pretreatment HOMA-IR insulin resistance index have poor therapeutic response than the ones with lower HOMA-IR index Thus it is reasonable to increase the therapeutic response of CHC patients by lowering insulin resistance Several pilot studies in western world have been conducted to evaluate this concept by adding oral hypoglycemic agents into pegylated interferon plus ribavirin treatment and have found beneficial effects of oral hypoglycemic agents on CHC genotype 1 infected patients Whether this concept still holds true in Taiwanese people remains unknown
To evaluate the effect of oral hypoglycemic agents on CHC genotype 1 infected Taiwanese patients we design this study and evaluate the virologic biochemical and histological responses of CHC patients receiving pegylated interferon plus ribavirin treatment and hope to identify similar beneficial effects of oral hypoglycemic agents in CHC Taiwanese patients
We plan to enroll about 80 chronic hepatitis C genotype 1 infected patients from the clinics into this study All patients should have informed consent not receive any interferon-based therapy or anti-viral medication abstinence from alcohol beverage for more than 6 months and conformed to the regulations of Bureau of National Health Insurance Taiwan All patients will be randomly assigned into 4 different treatment arms The patients assigned into the first 3 arms will receive one kind of the following oral hypoglycemic agents such as Acarbose Metformin or Pioglitazone for 12 weeks including 4 weeks of run-in period and 8 weeks of combination treatment with pegylated interferon alfa plus ribavirin From week 13 all the patients of the first 3 arms will receive pegylated interferon alfa plus ribavirin for 40 weeks The last arm is the control group all the patients in the last arm will receive standard pegylated interferon alfa plus ribavirin treatment for 48 weeks During the trial and 24 weeks after the end of treatment the serum HCV RNA levels clinical and biochemical data will be evaluated to determine the therapeutic response and adverse events of the patients
Recent studies have identified a close link between metabolic profiles insulin resistance and HCV infection Chronic hepatitis C CHC patients with higher pretreatment HOMA-IR insulin resistance index have poor therapeutic response than the ones with lower HOMA-IR index Thus it is reasonable to increase the therapeutic response of CHC patients by lowering insulin resistance Several pilot studies in western world have been conducted to evaluate this concept by adding oral hypoglycemic agents into pegylated interferon plus ribavirin treatment and have found beneficial effects of oral hypoglycemic agents on CHC genotype 1 infected patients Whether this concept still holds true in Taiwanese people remains unknown
To evaluate the effect of oral hypoglycemic agents on CHC genotype 1 infected Taiwanese patients we design this study and evaluate the virologic biochemical and histological responses of CHC patients receiving pegylated interferon plus ribavirin treatment and hope to identify similar beneficial effects of oral hypoglycemic agents in CHC Taiwanese patients
We plan to enroll about 80 chronic hepatitis C genotype 1 infected patients from the clinics into this study All patients should have informed consent not receive any interferon-based therapy or anti-viral medication abstinence from alcohol beverage for more than 6 months and conformed to the regulations of Bureau of National Health Insurance Taiwan All patients will be randomly assigned into 4 different treatment arms The patients assigned into the first 3 arms will receive one kind of the following oral hypoglycemic agents such as Acarbose Metformin or Pioglitazone for 12 weeks including 4 weeks of run-in period and 8 weeks of combination treatment with pegylated interferon alfa plus ribavirin From week 13 all the patients of the first 3 arms will receive pegylated interferon alfa plus ribavirin for 40 weeks The last arm is the control group all the patients in the last arm will receive standard pegylated interferon alfa plus ribavirin treatment for 48 weeks During the trial and 24 weeks after the end of treatment the serum HCV RNA levels clinical and biochemical data will be evaluated to determine the therapeutic response and adverse events of the patients
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