EUCTR2008-003591-22-ES
Active, not recruiting
Phase 1
A multi-centre, randomised, prospective, single-blinded, controlled study to investigate the efficacy and safety of a standardised maintenance dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus placebo in patients with iron deficiency caused by inflammatory bowel disease Estudio aleatorizado, multicéntrico, prospectivo, simple ciego y controlado para investigar la eficacia y la seguridad de una pauta de dosis de mantenimiento normalizada de carboximaltosa férrica (FERINJECT®) administrada por vía intravenosa en comparación con placebo en pacientes con déficit de hierro causado por enfermedad inflamatoria intestinal
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Iron deficiency anaemia in patients with inflammatory bowel diseasePacientes con déficit de hierro causado por enfermedad inflamatoria intestinal
- Sponsor
- Vifor (International) Inc.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be entered into this study only if they meet all of the following criteria:
- •Signed informed consent.
- •Non\-anaemic patients treated in the FERGI CORRECTION study (Hb \=12 g/dL female, \=13 g/dL male), independent of ferritin value.
- •Normal levels of vitamin B12 and folic acid.
- •Females of child\-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Patients will not be entered into this study if they meet any of the following criteria:
- •Chronic alcohol abuse (alcohol consumption \>20 g/day).
- •Presence of portal hypertension with oesophageal varices.
- •History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
- •Known hypersensitivity to FERINJECT®.
- •History of acquired iron overload.
- •Myelodysplastic syndrome.
- •Pregnancy or lactation.
- •Known active infection, clinically significant overt bleeding, active malignancy.
- •Known chronic renal failure.
Outcomes
Primary Outcomes
Not specified
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