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Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

18 Years
70 Years
Open (Enrolling)
Hereditary Haemochromatosis

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Trial Information

Mi-Iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

There is mounting evidence that treatment of moderate iron overload in HFE related
hereditary haemochromatosis (HH) is not necessary. This project aims to undertake a
randomised patient-blinded trial of erythrocytapheresis compared to sham erythrocytapheresis
(using plasmapheresis) in individuals who have serum ferritin (SF) above the upper limit of
the normal range but < 1000ug/L (defined here as moderate iron overload) due to HFE
mutations and to compare the prevalence of symptoms and objective markers of disease in the
two treatment arms.

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 (> 50% for males and > 45% for females).

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 (> 30g/day in
males and 20g/day in females) or body mass index > 35.

4. Has had venesection therapy for HH in the last two years.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Martin B Delatycki

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austin Health/Murdoch Childrens Research Institute


Australia: Human Research Ethics Committee

Study ID:




Start Date:

June 2012

Completion Date:

March 2015

Related Keywords:

  • Hereditary Haemochromatosis
  • Hereditary haemochromatosis
  • Moderate iron overload
  • Serum ferritin
  • Treatment
  • Hemochromatosis
  • Iron Overload