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

Inflammatory Bowel Diseases Clinical Trial

— FRESH  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247816
• Other study ID #: ST10-01-401
• Status: Completed
• Start date: August 14, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: September 2020
• Source: Shield Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Shield Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex of Patient at Baseline	Sex of patient at Baseline - Male or Female	Baseline
Other	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
Other	Platelets Count at Baseline	Mean platelets count at baseline	Baseline
Other	Vitamin B12 Value at Baseline	Vitamin B12 mean value at baseline	Baseline
Other	Mean Corpuscular Volume at Baseline	Mean value of C-reactive protein (CRP) at Baseline	Baseline
Other	Mean Corpuscular Hb at Baseline	Mean corpuscular haemoglobin (MCH) at Baseline	Baseline
Primary	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	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)
Secondary	Change in Hb Levels at 12 Weeks	Change in Haemoglobin levels from baseline to Week 12	Baseline to Week 12 (permitting 10-16 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change in Transferrin Saturation at Week 4	Change in transferrin saturation (TSAT) at Week 4	Baseline to Week 4 (permitting 3 to 5 weeks)
Secondary	Change in Transferrin Saturation at Week 12	Change in transferrin saturation (TSAT) at Week 12	Baseline to Week 12
Secondary	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
Secondary	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
Secondary	Time From Diagnosis of IBD to Initiation of Feraccru	Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.	Baseline
Secondary	Time From Diagnosis of IDA to Initiation of Feraccru®	Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®	Baseline
Secondary	Prior IV Treatment History	Prior intravenous iron treatment history	Baseline
Secondary	Reason for Initiating Feraccru®	Reason(s) for initiation of Feraccru®	Baseline
Secondary	Percentage of Patients Who Discontinue Feraccru®	Percentage of patients who discontinue Feraccru® during the 12 weeks period	Baseline to week 12
Secondary	Reason for Discontinuing Feraccru®	Reasons for stopping will be collected as predefined common options and a free text field.	Baseline to week 12
Secondary	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.
Secondary	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