Clinical trial NCT03247816: Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Iron Deficiency
Inflammatory Bowel Diseases
Lead sponsor: Shield Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Real World subjects with IBD (Crohn's disease or ulcerative colitis) who are also diagnosed with mild-moderate IDA.

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 effectiveness, patterns of use and tolerability.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
timeFrame: 12 weeks (permitting 10-16 weeks)
Secondary outcomes:
measure: Change in Hb Levels at Week 4
timeFrame: Baseline to Week 4 (permitting 3 to 5 weeks)
measure: Change in Hb Levels at 12 Weeks
timeFrame: Baseline to Week 12 (permitting 10-16 weeks)
measure: Time to Normalisation of Hb Levels
timeFrame: Baseline to 12 weeks (permitting 10-16 weeks)
measure: Change in Serum Ferritin Levels at Week 4
timeFrame: Baseline to Week 4 (permitting 3 to 5 weeks)
measure: Change in Serum Ferritin Levels at Week 12
timeFrame: Baseline to Week 12 (permitting 10-16 weeks)
measure: Percentage of Patients With Normalised Ferritin Levels at 12 Weeks
timeFrame: Baseline to Week 12 (permitting 10-16 weeks)
measure: Time to Correction of Serum Ferritin Levels
timeFrame: Baseline to Week 12 (permitting 10 to 16 weeks)
measure: Change in Transferrin Saturation at Week 4
timeFrame: Baseline to Week 4 (permitting 3 to 5 weeks)
measure: Change in Transferrin Saturation at Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®
timeFrame: Baseline to Week 12
measure: Time to Correction of Transferrin Saturation
timeFrame: Baseline to Week 12
measure: Time From Diagnosis of IBD to Initiation of Feraccru
timeFrame: Baseline
measure: Time From Diagnosis of IDA to Initiation of Feraccru®
timeFrame: Baseline
measure: Prior IV Treatment History
timeFrame: Baseline
measure: Reason for Initiating Feraccru®
timeFrame: Baseline
measure: Percentage of Patients Who Discontinue Feraccru®
timeFrame: Baseline to week 12
measure: Reason for Discontinuing Feraccru®
timeFrame: Baseline to week 12
measure: Adverse Events That Are Related to and Caused by Feraccru®
timeFrame: For the duration of study, average of 12 weeks.
measure: Reason for Discontinuing Each Prior Oral Ferrous Product
timeFrame: Baseline
Other outcomes:
measure: Sex of Patient at Baseline
timeFrame: Baseline
measure: Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)
timeFrame: Baseline
measure: Platelets Count at Baseline
timeFrame: Baseline
measure: Vitamin B12 Value at Baseline
timeFrame: Baseline
measure: Mean Corpuscular Volume at Baseline
timeFrame: Baseline
measure: Mean Corpuscular Hb at Baseline
timeFrame: Baseline
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: