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Chronic Hepatitis CPhase 2NCT00433108

Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C

A Phase 2 study testing Mitoquinone mesylate (MitoQ) in people with Chronic Hepatitis C, run by Antipodean Pharmaceuticals, Inc. at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Mitoquinone mesylate (MitoQ)
How many people
30 participants
Where
2 sitesNew Zealand
Study dates
Mar 2007to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures
  • Aged between 18-65 years
  • Documented history of chronic HCV infection (for at least 6 months prior to study entry) as diagnosed by either:
  • Anti-HCV positive or
  • HCV RNA viral load positive by PCR
  • Be a non-responder to or unsuitable for interferon based therapy.
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  • Have liver inflammation, as defined by either AST and/or ALT levels 2-10 x ULN on at least 1 previous occasion within the past 6 months and at Pre-treatment visit
  • alpha-fetoprotein (AFP) less than/equal to 50µg/L
  • Hemoglobin ≥100g/L, platelet count ≥75x109/L, and white blood cell count ≥1.5x109/L
  • Males, or females who are not of child-bearing potential or who are taking adequate contraceptive measures. Female patients must be postmenopausal for at least 2 years prior to the study, surgically sterile, or using effective contraception for at least 2 months prior to starting study drug and until 28 days following the last dose of study drug. Acceptable methods of birth control include hormonal contraceptives, or double-barrier methods.Negative serum pregnancy test must be documented at the Pre-treatment visit (i.e. within 14 days of starting study drug)
  • Liver biopsy within past 3 years showing stage 2 fibrosis only (i.e. excludes cirrhosis and cancer); or within past 6 years showing stage 0 or 1 (no or minimal scarring).

Who cannot join

  • Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
  • Presence of human immunodeficiency virus (HIV)
  • Co-infection with hepatitis B virus (HBV)
  • Last baseline AST and ALT level prior to Day 1 of <2.0xULN
  • Renal impairment (creatinine>1.5 x ULN) or hepatorenal syndrome
  • Chronic pancreatitis
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  • Hospitalization for liver disease within 60 days of the Pre-treatment visit
  • Liver transplant recipients
  • Use of drug therapy for Hepatitis C, including the use of:
  • drugs with presumed anti-Hepatitis C activity in the past 3 months
  • corticosteroids in the past 30 days
  • drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days
  • Any patient who admits to using or has a positive screening test for: amphetamines, barbiturates, pethidine, benzodiazepine, cocaine, methadone, opiates, phencyclidine or propoxyphene (unless medically prescribed and in stable doses for at least 30 days)
  • Alcohol consumption >5 units per week
  • Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial
  • History of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded
  • Use of antioxidants (Coenzyme Q10 and idebenone) at doses ≥300mg/day within 120 days prior to enrolment. Doses between 25-300mg/day are not an exclusion and require a 7 day washout prior to study enrolment
  • Use of dietary supplements (vitamin or mineral) at constant doses throughout the study (unless medically prescribed). Patients choosing to stop using supplements are not excluded and require a 7 day washout period prior to study enrolment
  • History of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
  • Unable to swallow tablets whole.

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

  • New Zealand Liver Unit, Auckland City Hospital

    Auckland

  • Waikato Hospital

    Hamilton

Other trials in New Zealand

About this study

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

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.

Read the 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 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.

Being tested
Mitoquinone mesylate (MitoQ)
Keywords
Hepatitis C, antioxidant, liver enzymes, ALT
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitoquinone mesylate (MitoQ)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum ALT concentration at Day 28 compared with baseline

Secondary outcomes (2)

  1. Efficacy: Change in AST at Day 28 compared with baseline, change in HCV RNA viral load, plasma Mitoquinone concentration for population pharmacokinetics

  2. Safety: Adverse events, vital signs, ECG, lab tests (biochemistry, hematology, urinalysis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2007 (estimated)
  2. Study startMar 2007
  3. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433108
Sponsor's protocol ID
MTQ-HC-001
Status last verified
Aug 2008
First submitted
7 Feb 2007
Last updated
14 Aug 2008
Results posted
No
Data monitoring committee
No

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.

    PubMed 20492507

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoquinone mesylate (MitoQ) in people with Chronic Hepatitis C, run by Antipodean Pharmaceuticals, Inc. at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum ALT concentration at Day 28 compared with baseline. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.

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