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

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.

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Anemia, Iron Deficiency

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

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks (permitting 10-16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hb Levels at Week 4	Change in Haemoglobin levels from baseline to Week 4	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	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.	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	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	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.	Baseline to Week 12 (permitting 10-16 weeks)
Time to Correction of Serum Ferritin Levels	Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.	Baseline to Week 12 (permitting 10 to 16 weeks)
Change in Transferrin Saturation at Week 4	Change in transferrin saturation (TSAT) at Week 4	Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Transferrin Saturation at Week 12	Change in transferrin saturation (TSAT) at Week 12	Baseline to Week 12
Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®	Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.	Baseline to Week 12
Time to Correction of Transferrin Saturation	Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.	Baseline to Week 12
Time From Diagnosis of IBD to Initiation of Feraccru	Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.	Baseline
Time From Diagnosis of IDA to Initiation of Feraccru®	Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®	Baseline
Prior IV Treatment History	Prior intravenous iron treatment history	Baseline
Reason for Initiating Feraccru®	Reason(s) for initiation of Feraccru®	Baseline
Percentage of Patients Who Discontinue Feraccru®	Percentage of patients who discontinue Feraccru® during the 12 weeks period	Baseline to week 12
Reason for Discontinuing Feraccru®	Reasons for stopping will be collected as predefined common options and a free text field.	Baseline to week 12
Adverse Events That Are Related to and Caused by Feraccru®	Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®	For the duration of study, average of 12 weeks.
Reason for Discontinuing Each Prior Oral Ferrous Product	Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex of Patient at Baseline	Sex of patient at Baseline - Male or Female	Baseline
Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)	Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)	Baseline
Platelets Count at Baseline	Mean platelets count at baseline	Baseline
Vitamin B12 Value at Baseline	Vitamin B12 mean value at baseline	Baseline
Mean Corpuscular Volume at Baseline	Mean value of C-reactive protein (CRP) at Baseline	Baseline
Mean Corpuscular Hb at Baseline	Mean corpuscular haemoglobin (MCH) at Baseline	Baseline

Collaborators and Investigators

• Sponsor: Shield Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2017
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: March 12, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (ACTUAL): August 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Anemia, Hypochromic; Iron Metabolism Disorders; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Anemia; Intestinal Diseases
• Other Study ID Numbers: ST10-01-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No