Feraccru® Real World Effectiveness Study in Hospital Practice

• Research type

  Research Study

• Full title

  Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A real world study to describe the outcomes associated with the use of ferric maltol (Feraccru®) for the management of iron deficiency anaemia in patients with inflammatory bowel disease in the UK

• IRAS ID

  224829

• Contact name

  Fraser Cummings

• Contact email

  Fraser.Cummings@uhs.nhs.uk

• Sponsor organisation

  Shield Therapeutics PLC

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  This is an observational, multicentre, descriptive research study. The target patient group will be patients with inflammatory bowel disease (IBD) (Crohn’s disease [CD] or ulcerative colitis [UC]) who are also diagnosed with iron deficiency anaemia (IDA).
  The study will take place in 5 centres in the UK and will recruit approximately 100 patients. The centres will be secondary/tertiary care hospitals.

  The aim of the study is to describe the real-world use of ferric maltol (Feraccru®), and the characteristics and the clinical outcomes of patients with IBD and IDA who receive ferric maltol by following patients for 12 weeks.

  Data will be collected from patients’ medical records by trained data collectors. All patients will be invited to consent to allow a researcher access to their medical records for the purpose of data collection. There will be no change to routine patient management for the purpose of the study.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  17/LO/0511

• Date of REC Opinion

  3 Apr 2017

• REC opinion

  Further Information Favourable Opinion