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Clinical Trials/EUCTR2008-003591-22-AT
EUCTR2008-003591-22-AT
Active, not recruiting
Not Applicable

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

Vifor (International) Inc.0 sites200 target enrollmentSeptember 8, 2008
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ConditionsIron deficiency anaemia in patients with inflammatory bowel diseaseMedDRA version: 9.1Level: LLTClassification code 10055736Term: Iron deficiency anaemia secondary to blood loss (chronic)
DrugsFERINJECT 50 mg iron/ml solution for injection and infusion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Iron deficiency anaemia in patients with inflammatory bowel disease
Sponsor
Vifor (International) Inc.
Enrollment
200
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 8, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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.
  • •If VitB12/folate levels are below normal range, an appropriate supplementation should be started.
  • •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

Similar Trials

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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
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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 intestinalIron deficiency anaemia in patients with inflammatory bowel diseasePacientes con déficit de hierro causado por enfermedad inflamatoria intestinalMedDRA version: 9.1Level: LLTClassification code 10055736Term: Iron deficiency anaemia secondary to blood loss (chronic)
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