Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Shield Therapeutics
A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease. Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks): * Oral ferric maltol, 30 mg capsule bid. * Intravenous iron (ferric carboxy maltose) as per SPC In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits. Subject participation in the study will consist of 3 periods: * Screening: Up to 14 days * Randomised Treatment: 52 weeks * Post-treatment safety follow-up: 14 days after study medication discontinuation Primary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks. End of study evaluations will occur at Week 52 or premature discontinuation.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
