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Completed

NCT Number: NCT03247816

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

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.

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Key information

Conditions

Anemia, Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Inflammatory Bowel Diseases Intestinal Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Southampton General Hospital

Southampton, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

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

Secondary outcomes

  1. Change in Hb Levels at Week 4

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

    Change in Haemoglobin levels from baseline to Week 4

  2. Change in Hb Levels at 12 Weeks

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

    Change in Haemoglobin levels from baseline to Week 12

  3. Time to Normalisation of Hb Levels

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

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

  4. Change in Serum Ferritin Levels at Week 4

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

    Change in serum ferritin levels from baseline to week 4

  5. Change in Serum Ferritin Levels at Week 12

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

    Change in serum ferritin levels from baseline to week 12

  6. Percentage of Patients With Normalised Ferritin Levels at 12 Weeks

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

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

  7. Time to Correction of Serum Ferritin Levels

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

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

  8. Change in Transferrin Saturation at Week 4

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

    Change in transferrin saturation (TSAT) at Week 4

  9. Change in Transferrin Saturation at Week 12

    Time frame: Baseline to Week 12

    Change in transferrin saturation (TSAT) at Week 12

  10. Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®

    Time frame: Baseline to Week 12

    Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.

  11. Time to Correction of Transferrin Saturation

    Time frame: Baseline to Week 12

    Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.

  12. Time From Diagnosis of IBD to Initiation of Feraccru

    Time frame: Baseline

    Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.

  13. Time From Diagnosis of IDA to Initiation of Feraccru®

    Time frame: Baseline

    Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®

  14. Prior IV Treatment History

    Time frame: Baseline

    Prior intravenous iron treatment history

  15. Reason for Initiating Feraccru®

    Time frame: Baseline

    Reason(s) for initiation of Feraccru®

  16. Percentage of Patients Who Discontinue Feraccru®

    Time frame: Baseline to week 12

    Percentage of patients who discontinue Feraccru® during the 12 weeks period

  17. Reason for Discontinuing Feraccru®

    Time frame: Baseline to week 12

    Reasons for stopping will be collected as predefined common options and a free text field.

  18. Adverse Events That Are Related to and Caused by Feraccru®

    Time frame: For the duration of study, average of 12 weeks.

    Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®

  19. Reason for Discontinuing Each Prior Oral Ferrous Product

    Time frame: Baseline

    Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.

Other outcomes

  1. Sex of Patient at Baseline

    Time frame: Baseline

    Sex of patient at Baseline - Male or Female

  2. Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)

    Time frame: Baseline

    Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)

  3. Platelets Count at Baseline

    Time frame: Baseline

    Mean platelets count at baseline

  4. Vitamin B12 Value at Baseline

    Time frame: Baseline

    Vitamin B12 mean value at baseline

  5. Mean Corpuscular Volume at Baseline

    Time frame: Baseline

    Mean value of C-reactive protein (CRP) at Baseline

  6. Mean Corpuscular Hb at Baseline

    Time frame: Baseline

    Mean corpuscular haemoglobin (MCH) at Baseline

Sponsors and collaborators

Lead sponsor

Shield Therapeutics

Industry

Registry information

Official study 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.

Acronym: FRESH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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