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Transferrin Saturation and Asthenia in Hemochromatosis (HEMOSAT)

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ClinicalTrials.gov Identifier: NCT03356548
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Observational study.

Condition or disease
Hemochromatoses, Genetic

Detailed Description:

The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload.

Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia <50 by performing weekly bleeds.

The second phase, called maintenance, aims to maintain this ferritinemia <50 by performing bleeding every 1 to 6 months depending on the case.

The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels <50. This could reflect an incomplete control of their disease, and leads us to raise two points:

  • It is known that in some subjects, the Transferrin Saturation Coefficient remains high, despite ferritinemia <50; it is also known that this elevation of the Transferrin Saturation Coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1.
  • The asthenia observed in some patients in the maintenance phase could be linked to a high rate of Transferrin Saturation Coefficient.

Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .


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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : April 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemochromatosis




Primary Outcome Measures :
  1. Quality of life questionnaire SF 36 [ Time Frame: Through study completion, an average of 3 months ]
  2. Biological markers : Transferrin Saturation Coefficient [ Time Frame: Through study completion, an average of 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with genetic hemochromatosis HFE
Criteria
  • Inclusion criteria:

    • homozygous C282Y ;
    • in the maintenance phase for at least 6 months ;
    • follow-up at Rennes University Hospital ;
    • patient who has not expressed his opposition to participate in the study.
  • Exclusion criteria:

    • Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ;
    • Temporary: infectious syndrome within 7 days before bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356548


Locations
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France
Rennes University Hospital
Rennes, Britain, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Fabrice LAINE Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03356548     History of Changes
Other Study ID Numbers: 35RC17_3067_HEMOSAT
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemochromatosis
Asthenia
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Signs and Symptoms