N/A
Completed N=59
Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )
Anemia, Iron Deficiency · Inflammatory Bowel Disease
Source: ClinicalTrials.gov NCT03247816 ↗
Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Sep 2020
Primary outcomePrimary: The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. — 19; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®. |
19; 11 | — |
| SECONDARY Change in Hb Levels at Week 4 |
0.8 | — |
| SECONDARY Change in Hb Levels at 12 Weeks |
1.4 | — |
| SECONDARY Time to Normalisation of Hb Levels |
49.5 | — |
| SECONDARY Change in Serum Ferritin Levels at Week 4 |
11.9 | — |
| SECONDARY Change in Serum Ferritin Levels at Week 12 |
19.1 | — |
| SECONDARY Percentage of Patients With Normalised Ferritin Levels at 12 Weeks |
9 | — |
| SECONDARY Time to Correction of Serum Ferritin Levels |
68.0 | — |
| SECONDARY Change in Transferrin Saturation at Week 4 |
— | — |
| SECONDARY Change in Transferrin Saturation at Week 12 |
— | — |
| SECONDARY Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru® |
— | — |
| SECONDARY Time to Correction of Transferrin Saturation |
— | — |
| SECONDARY Time From Diagnosis of IBD to Initiation of Feraccru |
9.4 | — |
| SECONDARY Time From Diagnosis of IDA to Initiation of Feraccru® |
53.8 | — |
| SECONDARY Prior IV Treatment History |
24; 22; 13 | — |
| SECONDARY Reason for Initiating Feraccru® |
22; 15; 18; 7; 6; 11 | — |
| SECONDARY Percentage of Patients Who Discontinue Feraccru® |
49 | — |
| SECONDARY Reason for Discontinuing Feraccru® |
12; 5; 3; 3; 3; 2 | — |
| SECONDARY Adverse Events That Are Related to and Caused by Feraccru® |
1; 7; 9 | — |
| SECONDARY Reason for Discontinuing Each Prior Oral Ferrous Product |
4; 3; 6; 8; 4; 1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03247816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.