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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01631708
Registration number
NCT01631708
Ethics application status
Date submitted
24/06/2012
Date registered
29/06/2012
Date last updated
27/09/2016
Titles & IDs
Public title
Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?
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Scientific title
Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?
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Secondary ID [1]
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04609
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Universal Trial Number (UTN)
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Trial acronym
Mi-iron
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hereditary Haemochromatosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Metabolic and Endocrine
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Metabolic disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Erythrocytapheresis
Treatment: Surgery - Plasmapheresis
Active Comparator: Erythrocytapheresis - Erythrocytapheresis is a procedure whereby whole blood is drawn from an individual and all elements except erythrocytes are returned to the donor. An automated filtration process removes the erythrocytes.
Those in arm 1 will have third weekly erythrocytapheresis until their SF is returned to the normal range.
Sham Comparator: Plasmapheresis - In plasmapheresis, the plasma is removed by the automated filtration process whilst other blood elements including erythrocytes are returned to the subject.
Those in arm 2 will have plasmapheresis with the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm.
Treatment: Surgery: Erythrocytapheresis
To achieve a blinded randomised trial, apheresis treatment will be used. Those in arm 1 will have erythrocytapheresis reducing iron levels and those in arm 2 will have plasmapheresis and their iron levels will not be reduced.
An apheresis machine will be used to remove red blood cells only from the erythrocytapheresis group. Subjects will have third weekly treatments until SF levels are reduced to ~100 ug/L in accordance with current guidelines.
Treatment: Surgery: Plasmapheresis
An apheresis machine will be used to remove blood plasma only from the plasmapheresis group. Those in arm 2 will have the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm. Those in the sham arm will be offered to have venesection at their choice of venue or to have their SF normalised by erythrocytapheresis after the initial blinded part of the study. This will be done because it will not be known for some time if there is benefit from normalisation of SF and therefore leaving people with elevated SF that may be harmful.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Fatigue
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Assessment method [1]
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Modified Fatigue Impact Scale (MFIS). The MFIS is a shortened version of the Fatigue Impact Scale. This 21-item scale can be self completed and measures the impact of fatigue on physical, cognitive and psychosocial functioning. Each item is scored from 0 (never) to 4 (almost always) resulting in a score from 0-84. In addition, physical (0-36), cognitive (0-40) and psychosocial (0-8) subscale scores can be derived.
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Timepoint [1]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have approximately 6 third weekly treatments however this will vary depending on initial SF.
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Secondary outcome [1]
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Change in markers of liver fibrosis
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Assessment method [1]
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Liver fibrosis will be assessed using Hepascore and Fibrometer (blood tests) and transient elastography (ultrasound).
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Timepoint [1]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have on average 6 third weekly treatments (15 weeks).
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
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Medical Outcomes Study 36-item short form (SF36). As there are no specific quality of life tools available for HH, we will use this very widely used generic tool that has been used in a number of HH studies. This tool covers eight dimensions of health and wellbeing. One study found that individuals seen in a HH clinic and who had no clinical symptoms had significantly lower scores on a number of dimensions of the SF36 compared to population norms.
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Timepoint [2]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have on average 6 third weekly treatments (15 weeks).
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Secondary outcome [3]
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Depression and Anxiety
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Assessment method [3]
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The Hospital Anxiety and Depression Scale (HADS) is a brief self-report measure designed to screen for anxiety symptoms and depression symptoms in a hospital setting. It is composed of two seven-item subscales, the Anxiety (HADS-A) and Depression (HADS-D) subscales, and a 14-item total scale (HADS-T). Participants use a four-point Likert-type scale to rate how they have felt in the past week. It has been found to be valid and reliable in various populations.
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Timepoint [3]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have on average 6 third weekly treatments (15 weeks).
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Secondary outcome [4]
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Arthritis
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Assessment method [4]
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The presence and impact of arthritis will be measured by the Arthritis Impact Measurement Scales 2 short form. This is a 24 item validated scale that assesses the impact of arthritis on the individual over the past four weeks. We will also ascertain the use of arthritis medication at baseline and end of erythrocytapheresis/sham erythrocytapheresis.
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Timepoint [4]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have on average 6 third weekly treatments (15 weeks).
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Secondary outcome [5]
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Markers of oxidative stress
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Assessment method [5]
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To assess oxidative stress, we will measure F2-isoprostanes, a validated marker of cellular lipid oxidative damage, in urine and blood.
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Timepoint [5]
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Clinically and statistically significant change in measures taken at baseline and at the end of treatment will be compared. Patients will have on average 6 third weekly treatments (15 weeks).
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Eligibility
Key inclusion criteria
1. HFE C282Y homozygous.
2. Aged 18 - 70 years .
3. SF above the upper limit of the normal range of 300µg/L but less than 1000µg/L with a
currently or previously raised TS (>greater than the upper limit of normal for the
testing laboratory).
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Minimum age
18
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. HH due to genotypes other than HFE C282Y homozygosity.
2. Normal SF, SF > 1000µg/L.
3. Other major risk factor(s) for liver toxicity or other significant co-morbidities
including positivity for hepatitis B or C, excess alcohol consumption (> 60g/day in
males and 40g/day in females) or body mass index > 35.
4. Has had venesection therapy for HH in the last two years.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2016
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane and Woman's Hospital - Brisbane
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Recruitment hospital [2]
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Austin Health - Melbourne
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Recruitment hospital [3]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Recruitment postcode(s) [2]
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3081 - Melbourne
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Recruitment postcode(s) [3]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Austin Health
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Royal Brisbane and Women's Hospital
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Fremantle Hospital and Health Service
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Melbourne Health
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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The University of Queensland
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Address [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten
life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to
maintain normal iron levels. It is unclear, however, whether treatment is necessary when
individuals have moderate elevation of iron in the body. This research project will study the
effects of treatment in this group by assessing a number of scans, questionnaires and blood
tests in treated and untreated individuals.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01631708
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Martin B Delatycki
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Address
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Austin Health/Murdoch Childrens Research Institute
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01631708
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