Trial Details

Not Recruiting
Basic Information
Clinical ID c3322
Identifier EUCTR2008-003591-22-DE
Trial Title 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
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Iron deficiency anaemia in patients with inflammatory bowel disease MedDRA version: 9.1_Level: LLT_Classification code 10055736_Term: Iron deficiency anaemia secondary to blood loss (chronic)_
Interventions Trade Name: FERINJECT 50 mg iron/ml solution for injection and infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Ferric carboxymaltose Current Sponsor code: VIT-45 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Participant Information
Sponsor Vifor (International) Inc.
City -
Country/Region Estonia;Spain;Lithuania;Denmark;Austria;Germany;United Kingdom;Sweden
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -