NCT01810965: SAIFER

Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis

Completed NA Last updated 11 June 2021

What this trial tests

NA trial testing First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml) in Hemochromatosis Type 1 in 6 participants. Completed in 19 April 2019.

Timeline

3 June 2013

Primary endpoint
19 April 2019

19 April 2019

Quick facts

Lead sponsor	Rennes University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	3 June 2013
Primary completion	19 April 2019
Estimated completion	19 April 2019
Sites	1 location across France

Drugs / interventions tested

• First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml)

Conditions studied

• Hemochromatosis Type 1 — all drugs for Hemochromatosis Type 1 →

Sponsor

Rennes University Hospital

Who can join

18 and older, male only, with Hemochromatosis Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about 3/1000 white subjects (5/1000 in Brittany, France).

For the half of these predisposed subjects, the phenotypic expression of the disease needs a treatment. This treatment is based upon repeated bloodletting which is generally considered as simple, safe and effective.

Nevertheless, it is still questioned as regard its physiopathological justification and its clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse physiopathological effect could have clinical consequences and could be linked with articular consequences which can be aggravated by the treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Chronotherapy: Intuitive, Sound, Founded…But Not Broadly Applied.
   Selfridge JM, Gotoh T, Schiffhauer S, Liu J, et al · · 2016 · cited 51× · PMID 27699644 · DOI 10.1007/s40265-016-0646-4