NCT02680756

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Shield Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

Detailed description

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.

Conditions

• Anemia, Iron-Deficiency
• Inflammatory Bowel Disease
• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Ferric Maltol
DRUG	Ferric Carboxy Maltose

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-10-01
• Completion: 2019-01-01
• First posted: 2016-02-11
• Last updated: 2020-11-02
• Results posted: 2020-02-24

Locations

44 sites across 6 countries: United States, Belgium, France, Germany, Hungary, Spain