Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433108
Status:
COMPLETED
Last Update Posted:
2008-08-14
First Post:
2007-02-07
Brief Title:
Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
Sponsor:
Antipodean Pharmaceuticals Inc
Organization:
Antipodean Pharmaceuticals Inc
Study Overview
Official Title:
A Double-Blind Parallel Randomized Comparison of Two Doses of MitoQ and Placebo for the Treatment of Patients With Raised Liver Enzymes Due to Hepatitis C
Status:
COMPLETED
Status Verified Date:
2008-08
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:
A Phase 2 randomized double-blind parallel design trial of two doses of mitoquinone mesylate MitoQ and of placebo in patients with chronic Hepatitis C
MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and accumulates within mitochondria in organs such as liver brain heart skeletal muscle There is strong evidence for increased oxidative stress and mitochondrial damage leading to apoptosis via caspase activation Several studies have shown that MitoQ protects cells from apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in liver disease
It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with chronic Hepatitis C compared with placebo Approximately 36 patients who have been unresponsive or not suitable for interferon-based therapy will be enrolled at one centre Treatment duration will be 28 days with 28 days post-treatment follow-up
MitoQ is a mitochondria-targeted antioxidant that rapidly permeates the lipid bilayer and accumulates within mitochondria in organs such as liver brain heart skeletal muscle There is strong evidence for increased oxidative stress and mitochondrial damage leading to apoptosis via caspase activation Several studies have shown that MitoQ protects cells from apoptosis by acting as a caspase inhibitor and may be effective in reducing cell damage in liver disease
It is hypothesised that administration of MitoQ will lower raised ALT seen in patients with chronic Hepatitis C compared with placebo Approximately 36 patients who have been unresponsive or not suitable for interferon-based therapy will be enrolled at one centre Treatment duration will be 28 days with 28 days post-treatment follow-up
Detailed Description:
Hepatitis C is a viral liver infection that contributes significantly to the burden of chronic liver disease It is currently estimated that over 170 million individuals 3 of the worlds populationare infected In New Zealand an estimated 25000 people are living with hepatitis C virus HCV infection and prevalence is predicted to increase by 50 over the next 10 years HCV is primarily spread by blood-to-blood contact The single most important risk factor for acquiring HCV is the use of injected recreational drugs accounting for approximately 80 of infections
Unlike hepatitis B no hepatitis C vaccine is currently available In the absence of an effective vaccine the current treatment of choice is interferon and ribavirin However treatment of chronic HCV infection with interferon-alpha monotherapy does not achieve sustained virologic response Therefore it is important to develop alternative treatment strategies for patients who are unresponsive or intolerant to current antiviral therapy
The aim of this protocol is to compare two doses of a mitochondrial antioxidant treatment MitoQ and placebo for the treatment of patients with raised liver enzymes due to HCV infection Approximately 36 eligible patients with chronic HCV infection will be randomised to receive one of two doses of MitoQ or placebo in a 111 ratio Treatment duration will be 28 days with 28 days post-treatment follow-up
Unlike hepatitis B no hepatitis C vaccine is currently available In the absence of an effective vaccine the current treatment of choice is interferon and ribavirin However treatment of chronic HCV infection with interferon-alpha monotherapy does not achieve sustained virologic response Therefore it is important to develop alternative treatment strategies for patients who are unresponsive or intolerant to current antiviral therapy
The aim of this protocol is to compare two doses of a mitochondrial antioxidant treatment MitoQ and placebo for the treatment of patients with raised liver enzymes due to HCV infection Approximately 36 eligible patients with chronic HCV infection will be randomised to receive one of two doses of MitoQ or placebo in a 111 ratio Treatment duration will be 28 days with 28 days post-treatment follow-up
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