Status:
COMPLETED
Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )
Lead Sponsor:
Shield Therapeutics
Conditions:
Anemia, Iron Deficiency
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-99 years
Brief Summary
The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectivenes...
Detailed Description
The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectivenes...
Eligibility Criteria
Inclusion
- Male and female patients aged ≥ 18 years at the time of initiation .
- Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and \<13.0 g/dL in males, or Hb ≥9.5 g/dL and \<12.0 g/dL in females
- Serum ferritin concentration \<30 microgram/L or transferrin saturation of \<20% .
- Patient receiving Feraccru® since the time of UK launch in June 2016.
Exclusion
- Patient receiving Feraccru® as part of an interventional clinical trial.
- Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
- Patient with an IBD flare, as determined by the clinician.
- Patient with medical records that are not available for review.
- Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period
Key Trial Info
Start Date :
August 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03247816
Start Date
August 14 2017
End Date
October 1 2018
Last Update
October 23 2020
Active Locations (1)
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1
Southampton General Hospital
Southampton, United Kingdom