Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00433108




Registration number
NCT00433108
Ethics application status
Date submitted
7/02/2007
Date registered
9/02/2007
Date last updated
14/08/2008

Titles & IDs
Public title
Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
Scientific 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
Secondary ID [1] 0 0
MTQ-HC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in serum ALT concentration at Day 28 compared with baseline
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Efficacy: Change in AST at Day 28 compared with baseline, change in HCV RNA viral load, plasma Mitoquinone concentration for population pharmacokinetics
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Safety: Adverse events, vital signs, ECG, lab tests (biochemistry, hematology, urinalysis)
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
1. Willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures
2. Aged between 18-65 years
3. Documented history of chronic HCV infection (for at least 6 months prior to study entry) as diagnosed by either:

1. Anti-HCV positive or
2. HCV RNA viral load positive by PCR
4. Be a non-responder to or unsuitable for interferon based therapy.
5. 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
6. alpha-fetoprotein (AFP) less than/equal to 50µg/L
7. Hemoglobin =100g/L, platelet count =75x109/L, and white blood cell count =1.5x109/L
8. 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)
9. 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).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
2. Presence of human immunodeficiency virus (HIV)
3. Co-infection with hepatitis B virus (HBV)
4. Last baseline AST and ALT level prior to Day 1 of <2.0xULN
5. Renal impairment (creatinine>1.5 x ULN) or hepatorenal syndrome
6. Chronic pancreatitis
7. Hospitalization for liver disease within 60 days of the Pre-treatment visit
8. Liver transplant recipients
9. Use of drug therapy for Hepatitis C, including the use of:

1. drugs with presumed anti-Hepatitis C activity in the past 3 months
2. corticosteroids in the past 30 days
3. drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days
10. 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)
11. Alcohol consumption >5 units per week
12. 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
13. 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. 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
15. 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
16. History of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including Coenzyme Q10 and idebenone
17. Unable to swallow tablets whole.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antipodean Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward J Gane, MBChB
Address 0 0
Liver Transplant Unit, Auckland City Hospital, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00433108