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

September 29, 2020 updated by: Shield Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks (permitting 10-16 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 4 (permitting 3 to 5 weeks)
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
Baseline to Week 12 (permitting 10-16 weeks)
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.
Baseline to 12 weeks (permitting 10-16 weeks)
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
Baseline to Week 4 (permitting 3 to 5 weeks)
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
Baseline to Week 12 (permitting 10-16 weeks)
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.
Baseline to Week 12 (permitting 10-16 weeks)
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.
Baseline to Week 12 (permitting 10 to 16 weeks)
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
Baseline to Week 4 (permitting 3 to 5 weeks)
Change in Transferrin Saturation at Week 12
Time Frame: Baseline to 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®
Time Frame: Baseline to Week 12
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
Time Frame: Baseline to Week 12
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 Frame: Baseline
Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.
Baseline
Time From Diagnosis of IDA to Initiation of Feraccru®
Time Frame: Baseline
Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®
Baseline
Prior IV Treatment History
Time Frame: Baseline
Prior intravenous iron treatment history
Baseline
Reason for Initiating Feraccru®
Time Frame: Baseline
Reason(s) for initiation of Feraccru®
Baseline
Percentage of Patients Who Discontinue Feraccru®
Time Frame: Baseline to week 12
Percentage of patients who discontinue Feraccru® during the 12 weeks period
Baseline to week 12
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.
Baseline to week 12
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®
For the duration of study, average of 12 weeks.
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.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex of Patient at Baseline
Time Frame: Baseline
Sex of patient at Baseline - Male or Female
Baseline
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)
Baseline
Platelets Count at Baseline
Time Frame: Baseline
Mean platelets count at baseline
Baseline
Vitamin B12 Value at Baseline
Time Frame: Baseline
Vitamin B12 mean value at baseline
Baseline
Mean Corpuscular Volume at Baseline
Time Frame: Baseline
Mean value of C-reactive protein (CRP) at Baseline
Baseline
Mean Corpuscular Hb at Baseline
Time Frame: Baseline
Mean corpuscular haemoglobin (MCH) at Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shield Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 14, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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