Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371579
Status:
WITHDRAWN
Last Update Posted:
2015-06-03
First Post:
2006-09-01
Brief Title:
Rosuvastatin for Hepatitis C
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Treatment With Rosuvastatin in Patients With Hepatitis C
Status:
WITHDRAWN
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no actual patients recruited within year 1 after ethical committee approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Determine if maximum doses of rosuvastatin are safe in patients infected with hepatitis C and if the so called pleiotropic effects of rosuvastatin cause a decrease in the HCV viral load
Primary study parameters 1 to which extend causes rosuvastatin serious side effects like rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C 2 does treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load 3 Is a decrease in LDL correlated to a decrease in HCV-RNA load
Primary study parameters 1 to which extend causes rosuvastatin serious side effects like rhabdomyolysis and hepatotoxicity in patients chronically infected with hepatitis C 2 does treatment with rosuvastatin in HCV infected patients lead to lower HCV-RNA viral load 3 Is a decrease in LDL correlated to a decrease in HCV-RNA load
Detailed Description:
Study design its a pilot study in which the patients form their own control group A total of 10 patients will be included To evaluate the effect of maximum doses of rosuvastatin on liver function and side effects first 2 patients will be treated and evaluated If they experience no serious adverse events then a further 8 patients will be included The dose of rosuvastatin will be increased over a period of 4 weeks
Intervention based on experience in treating dyslipidemia gradually increasing the dose of rosuvastatin diminishes the experienced side effects and decreases the chances of developing hepatotoxicity Therefore in this study we chose to increase the dose see flowchart Patients will start with 5 mg a day wich will be increased after 1 week to 10 mg per day After the second week of therapy a further increase to 20 mg per day is executed This dose will be given for another 2 weeks At week 4 of treatment a further increase to 40 mg is done
Intervention based on experience in treating dyslipidemia gradually increasing the dose of rosuvastatin diminishes the experienced side effects and decreases the chances of developing hepatotoxicity Therefore in this study we chose to increase the dose see flowchart Patients will start with 5 mg a day wich will be increased after 1 week to 10 mg per day After the second week of therapy a further increase to 20 mg per day is executed This dose will be given for another 2 weeks At week 4 of treatment a further increase to 40 mg is done
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