Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
|First Received Date ICMJE||February 7, 2007|
|Last Updated Date||August 12, 2008|
|Start Date ICMJE||March 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in serum ALT concentration at Day 28 compared with baseline|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00433108 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C|
|Official Title ICMJE||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|
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.
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 world's population)are infected. In New Zealand, an estimated 25,000 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 1:1:1 ratio. Treatment duration will be 28 days with 28 days post-treatment follow-up.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Condition ICMJE||Chronic Hepatitis C|
|Intervention ICMJE||Drug: Mitoquinone mesylate (MitoQ)|
|Study Arms||Not Provided|
|Publications *||Gane EJ, Weilert F, Orr DW, Keogh GF, Gibson M, Lockhart MM, Frampton CM, Taylor KM, Smith RA, Murphy MP. The mitochondria-targeted anti-oxidant mitoquinone decreases liver damage in a phase II study of hepatitis C patients. Liver Int. 2010 Aug;30(7):1019-26. doi: 10.1111/j.1478-3231.2010.02250.x. Epub 2010 May 18.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||New Zealand|
|Removed Location Countries|
|NCT Number ICMJE||NCT00433108|
|Other Study ID Numbers ICMJE||MTQ-HC-001|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Antipodean Pharmaceuticals, Inc.|
|Collaborators ICMJE||Not Provided|
|PRS Account||Antipodean Pharmaceuticals, Inc.|
|Verification Date||August 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP