A Study to Compare MitoQ and Placebo to Treat Non-alcoholic Fatty Liver Disease (NAFLD)
NCT ID: NCT01167088
Last Updated: 2011-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
110 participants
INTERVENTIONAL
2010-11-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Mitoquinone mesylate tablets (MitoQ)
Mitoquinone mesylate
2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
Matching placebo tablet
Placebo
Placebo
Interventions
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Mitoquinone mesylate
2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. NAFLD as determined by raised ALT (\> 1.5 x ULN corresponding to \>29U/L for females and \>45U/L for males\] in the screening period and on at least two other occasions in the previous 6 months) and ultrasound evidence of steatosis (in the previous 12 months).
3. Be aged between 18 - 70 years on the day of consent
4. Expect to not require or make any changes in all their current concomitant medications (prescribed and over-the-counter) for the duration of their participation in the study
5. Female patients with reproductive potential must have a negative serum pregnancy test within 14 days prior to start of trial and must agree to use a medically acceptable method of contraception throughout the treatment period and for 1 month after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive pessary)
Exclusion Criteria
2. Hepatocellular carcinoma (HCC) or suspicion of HCC
3. Presence of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV)
4. Renal impairment (creatinine \> 1.5 x ULN) or hepatorenal syndrome
5. Chronic pancreatitis
6. Hospitalization for liver disease within 60 days of the baseline visit
7. Previously diagnosed diabetes / treatment with insulin sensitizing agents
8. Severe or morbid obesity (BMI\>40kg/m2)
9. ALT or AST \> 10 times ULN
10. Liver transplant recipients
11. Corticosteroids in the past 30 days
12. Any participant 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
13. A 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
14. Females who are pregnant or breastfeeding
15. Use of Coenzyme Q10, either prescribed or purchased over-the-counter, are prohibited during the study, except for doses of up to 25mg/day which have been stable for 30 days prior to baseline. Higher doses require a 7 day washout prior to baseline.
16. Use of Vitamin E, either prescribed or purchased over-the-counter, are prohibited during the study, except for doses of up to 200IU/day which have been stable for 30 days prior to baseline. Higher doses require a 90 day washout prior to baseline.
17. Any changes to prescription medication in the 30 days prior to baseline
18. A history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
19. Unable to swallow tablets whole
20. Patients with histological or clinical evidence of established cirrhosis
21. Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the patient's best interest to participate in this study
18 Years
70 Years
ALL
No
Sponsors
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Antipodean Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Antipodean Pharmaceuticals Inc
Principal Investigators
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Chris Day, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Newcastle University Medical School, UK
Locations
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Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2010-021368-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MTQ-LD-001
Identifier Type: -
Identifier Source: org_study_id
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