PPI in secondary hemochromatosis.

Phase 1

• Conditions: Iron overload (secondary hemochromatosis) in non-transfusion dependent forms of hereditary anemias. Iron overload and hereditary anemia are a growing, underestimated emerging health care problem.; MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851; MedDRA version: 20.0Level: LLTClassification code 10057875Term: Secondary haemochromatosisSystem Organ Class: 100000004861; MedDRA version: 20.0Level: HLTClassification code 10022979Term: Iron excessSystem Organ Class: 100000004861; MedDRA version: 20.0Level: LLTClassification code 10055610Term: HemoglobinopathySystem Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10074356Term: Non-transfusion dependent thalassemiaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-003777-34-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

oDiagnosis of hereditary anemia: hemoglobinopathy (including all sickle cell syndromes and beta-thalassemia), sideroblastic anemia, congenital dyserythropoietic anemia or an erythrocyte enzyme deficiency.
oHemoglobin before study inclusion <7.0 mmol/L
oClinically stable and relevant iron overload defined as either one of:
- a baseline LIC measurement by MRI between 3 and 15 mg Fe/g without having received iron chelation 2 months prior to entering the study.
- OR a baseline LIC measurement by MRI between 3 and 15 mg Fe/g on stable chelation therapy (deferasirox, deferoxamine or deferiprone), with documented stable dosage the preceding 2 months and no expected dose reductions or increases the next two years.
oAged more than 18 years and able to sign informed consent.
oSerum transferrin saturation higher than 0.40 once during the preceding 24 months.
oReceived less than 10 units of blood during the preceding 12 months.
oIs expected to receive less than 4 units fo blood during the following 12 months
oIs not splenectomized during the preceding 24 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

oPregnancy.
oLiver cirrhosis.
oHeart failure.
oSevere cardiac iron overload defined as MRI T2* < 20 ms.
oSevere liver iron overload defined as MRI LIC > 15 mg Fe/g dw.
oExpected poor compliance.
oCurrently taking PPI and not able to stop for personal or medical reasons.
oPatients that are being phlebotomized as treatment for iron overload.
oCurrent peptic ulcer disease, gastro-intestinal bleeding or other causes of blood loss.
oContra-indication for esomeprazole use.
oConcomitant use of clopidogrel.
oContra-indication for MRI.
oReceived more than 4 units blood during one of the treatment periods of 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified