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

NCT03247816 | Completed Results

• 1 other identifier: ST10-01-401
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron Deficiency; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in Hb Levels at Week 4

  Baseline to Week 4 (permitting 3 to 5 weeks)

• Change in Hb Levels at 12 Weeks

  Baseline to Week 12 (permitting 10-16 weeks)

• Time to Normalisation of Hb Levels

  Baseline to 12 weeks (permitting 10-16 weeks)

• Change in Serum Ferritin Levels at Week 4

  Baseline to Week 4 (permitting 3 to 5 weeks)

• Change in Serum Ferritin Levels at Week 12

  Baseline to Week 12 (permitting 10-16 weeks)

Other Outcomes (6)

• Sex of Patient at Baseline

  Baseline

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

  Baseline

• Platelets Count at Baseline

  Baseline

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shield Therapeutics: lead

Study Sites (1)

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.

Results Point of Contact

• Title: Jackie Mitchell MA DPhil
• Organization: Shield TX (UK) Limited

jmitchell@shieldtx.com

+44 (0) 191 511 8515

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: August 14, 2017
• Study Start: August 14, 2017
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 23, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)