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

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ClinicalTrials.gov Identifier: NCT03247816
Recruitment Status : Not yet recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Shield Therapeutics

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. 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

Condition or disease
Anemia, Iron Deficiency Inflammatory Bowel Diseases

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Estimated Study Start Date : August 14, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The percentage of patients with normalised Hb levels at 12 weeks after initiation of Feraccru®. [ Time Frame: 12 weeks from baseline ]
    Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.


Secondary Outcome Measures :
  1. Change in Hb levels at 4 and 12 weeks after initiation of Feraccru® [ Time Frame: Weeks 4 and 12 after initiation. ]
    Where data is available

  2. Time to normalisation of Hb levels after initiation of Feraccru [ Time Frame: Baseline to 12 weeks ]
    Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

  3. Change in serum ferritin levels at 4 and 12 weeks after initiation of Feraccru® [ Time Frame: Weeks 4 and 12 after initiation. ]
  4. Percentage of patients with normalised ferritin levels at 12 weeks after initiation of Feraccru® [ Time Frame: 12 weeks after initiation. ]
    Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.

  5. Time to correction of serum ferritin levels after initiation of Feraccru® [ Time Frame: Baseline to 12 weeks ]
    Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.

  6. Change in transferrin saturation at 4 and 12 weeks after initiation of Feraccru® [ Time Frame: Weeks 4 and 12 after initiation ]
  7. Percentage of patients with normalised transferrin saturation at 12 weeks after initiation of Feraccru® [ Time Frame: 12 weeks after initiation ]
    Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.

  8. Time to correction of transferrin saturation after initiation of Feraccru® [ Time Frame: Time to correction up to 12 weeks. ]
    Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.

  9. Age of patient at diagnosis: (Date of birth mm/yy) [ Time Frame: Baseline ]
  10. Folate value at baseline [ Time Frame: Baseline ]
  11. Time from diagnosis of IBD to initiation of Feraccru® [ Time Frame: Baseline ]
  12. Time from diagnosis of IDA to initiation of Feraccru® [ Time Frame: Baseline ]
    Previous iron treatments will be collected as free text, this will be reported as a distribution.

  13. Iron Treatment history [ Time Frame: Baseline ]
  14. Reason(s) for discontinuing each prior oral ferrous product [ Time Frame: Baseline ]
    Reasons for stopping will be collected as predefined common options and a free text field. This will be reported as a distribution.

  15. Reason(s) for initiating Feraccru® [ Time Frame: Baseline ]
    Tick box option plus free text option within the CRF

  16. Percentage of patients who discontinue Feraccru® [ Time Frame: Baseline to week 12 ]
  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. This will be reported as a distribution.

  18. Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru [ Time Frame: For the duration of study, average of 12 weeks. ]
  19. C-reactive protein (CRP) at baseline [ Time Frame: Baseline ]

Other Outcome Measures:
  1. Sex of patient at baseline [ Time Frame: Baseline ]
    Male or Female

  2. Type of IBD at baseline (Crohn's Disease or Ulcerative Colitis) [ Time Frame: Baseline ]
  3. Platelets count at baseline [ Time Frame: Baseline ]
  4. Vitamin B12 value at baseline [ Time Frame: Baseline ]
  5. Mean corpuscular volume at baseline [ Time Frame: Baseline ]
  6. Mean corpuscular Hb at baseline [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247816


Contacts
Contact: Dr Mark Sampson 0207 186 8513 MSampson@shieldtherapeutics.com
Contact: Lesley Jones 0755 736 7810 Ljones@shieldtx.com

Sponsors and Collaborators
Shield Therapeutics

Responsible Party: Shield Therapeutics
ClinicalTrials.gov Identifier: NCT03247816     History of Changes
Other Study ID Numbers: ST10-01-401
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Intestinal Diseases
Inflammatory Bowel Diseases
Hematologic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases