Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

Shield Therapeutics59 enrolled

Overview

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 effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anemia, Iron Deficiency Inflammatory Bowel Diseases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

Southampton General Hospital

Southampton, United Kingdom

Outcomes

Primary Outcomes

The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.

Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

Time frame: 12 weeks (permitting 10-16 weeks)

Secondary Outcomes

Change in Hb Levels at Week 4

Change in Haemoglobin levels from baseline to Week 4

Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)

Change in Hb Levels at 12 Weeks

Change in Haemoglobin levels from baseline to Week 12

Time frame: Baseline to Week 12 (permitting 10-16 weeks)

Time to Normalisation of Hb Levels

Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.

Time frame: Baseline to 12 weeks (permitting 10-16 weeks)

Change in Serum Ferritin Levels at Week 4

Change in serum ferritin levels from baseline to week 4

Time frame: Baseline to Week 4 (permitting 3 to 5 weeks)

Change in Serum Ferritin Levels at Week 12

Change in serum ferritin levels from baseline to week 12

Time frame: Baseline to Week 12 (permitting 10-16 weeks)

Percentage of Patients With Normalised Ferritin Levels at 12 Weeks

Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.

Time frame: Baseline to Week 12 (permitting 10-16 weeks)

Data from ClinicalTrials.gov

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