Trial Outcomes & Findings for Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH ) (NCT NCT03247816)

Results Overview

Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

Recruitment status

COMPLETED

Target enrollment

59 participants

Primary outcome timeframe

12 weeks (permitting 10-16 weeks)

Results posted on

2020-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Number of Eligible Subjects Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
Overall Study STARTED	59
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Number of Eligible Subjects Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
Overall Study Adverse Event	12
Overall Study Physician Decision	3
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	10
Overall Study Missing Feraccru stop date	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Number of Eligible Subjects n=59 Participants Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
Age, Customized 18 < 25	8 Participants n=59 Participants
Age, Customized 25 < 35	16 Participants n=59 Participants
Age, Customized 35 < 45	12 Participants n=59 Participants
Age, Customized 45 < 55	8 Participants n=59 Participants
Age, Customized 55 < 65	5 Participants n=59 Participants
Age, Customized >65	10 Participants n=59 Participants
Sex: Female, Male Female	38 Participants n=59 Participants
Sex: Female, Male Male	21 Participants n=59 Participants
Region of Enrollment United Kingdom	59 participants n=59 Participants
Baseline Haemoglobin	11.1 g/dl STANDARD_DEVIATION 0.9 • n=59 Participants
Type of Inflammatory Bowel Disease Crohn's Disease (CD)	28 Participants n=59 Participants
Type of Inflammatory Bowel Disease Ulcerative Colitis (UC)	28 Participants n=59 Participants
Type of Inflammatory Bowel Disease Unspecified	3 Participants n=59 Participants

PRIMARY outcome

Timeframe: 12 weeks (permitting 10-16 weeks)

Population: Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru.

Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=30 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks n=30 Participants Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.	19 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4 (permitting 3 to 5 weeks)

Population: Subjects with available Hb at Week 4 (permitting 3 to 5 weeks).

Change in Haemoglobin levels from baseline to Week 4

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=17 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Change in Hb Levels at Week 4	0.8 g/dl Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (permitting 10-16 weeks)

Population: Subjects with available Hb at Week 12 (permitting 10-16 weeks).

Change in Haemoglobin levels from baseline to Week 12

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=30 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Change in Hb Levels at 12 Weeks	1.4 g/dl Standard Deviation 1.7	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks (permitting 10-16 weeks)

Population: Subjects with available Hb at Week 12 (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.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=30 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Time to Normalisation of Hb Levels	49.5 days Standard Deviation 25.6	—

SECONDARY outcome

Timeframe: Baseline to Week 4 (permitting 3 to 5 weeks)

Population: Subjects with available ferritin measurements at Week 4 (permitting 3 to 5 weeks).

Change in serum ferritin levels from baseline to week 4

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=7 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Change in Serum Ferritin Levels at Week 4	11.9 ug/ml Standard Deviation 12.5	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (permitting 10-16 weeks)

Population: Subjects with available ferritin measurement at Week 12 (permitting 10-16 weeks)

Change in serum ferritin levels from baseline to week 12

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=17 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Change in Serum Ferritin Levels at Week 12	19.1 ug/ml Standard Deviation 36.0	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (permitting 10-16 weeks)

Population: Subjects with available ferritin measurements at 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.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=22 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Percentage of Patients With Normalised Ferritin Levels at 12 Weeks	9 Participants	—

SECONDARY outcome

Timeframe: Baseline to Week 12 (permitting 10 to 16 weeks)

Population: Subjects with available ferritin measurement at 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.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=16 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Time to Correction of Serum Ferritin Levels	68.0 days Standard Deviation 25.1	—

SECONDARY outcome

Timeframe: Baseline

Prior intravenous iron treatment history

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Prior IV Treatment History ≥1 course of intravenous iron	24 Participants	—
Prior IV Treatment History not received previous IV	22 Participants	—
Prior IV Treatment History unkown	13 Participants	—

SECONDARY outcome

Timeframe: Baseline

Population: The initiation reasons are not exclusive per patient. Some subjects had multiple reasons for initiating Feraccru®.

Reason(s) for initiation of Feraccru®

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=92 initiation reasons Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Reason for Initiating Feraccru® Intolerance to ferrous sulphate	22 initiation reasons	—
Reason for Initiating Feraccru® Intolerance to ferrous fumarate	15 initiation reasons	—
Reason for Initiating Feraccru® Intolerance to ferrous gluconate	18 initiation reasons	—
Reason for Initiating Feraccru® Intolerance to oral iron	7 initiation reasons	—
Reason for Initiating Feraccru® Clinician decision	6 initiation reasons	—
Reason for Initiating Feraccru® Not recorded	11 initiation reasons	—
Reason for Initiating Feraccru® Other	13 initiation reasons	—

SECONDARY outcome

Timeframe: Baseline to week 12

Percentage of patients who discontinue Feraccru® during the 12 weeks period

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Percentage of Patients Who Discontinue Feraccru®	49 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: The categories are not mutually exclusive so a single subject could have multiple reasons listed.

Reasons for stopping will be collected as predefined common options and a free text field.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Reason for Discontinuing Feraccru® Abdominal pain	12 percentage of participants	—
Reason for Discontinuing Feraccru® Clinician decision	5 percentage of participants	—
Reason for Discontinuing Feraccru® Diarrhoea	3 percentage of participants	—
Reason for Discontinuing Feraccru® Constipation	3 percentage of participants	—
Reason for Discontinuing Feraccru® Treatment complete	3 percentage of participants	—
Reason for Discontinuing Feraccru® Lack of efficacy	2 percentage of participants	—
Reason for Discontinuing Feraccru® Nausea	2 percentage of participants	—
Reason for Discontinuing Feraccru® Not known	17 percentage of participants	—
Reason for Discontinuing Feraccru® Other	5 percentage of participants	—

SECONDARY outcome

Timeframe: 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®

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Adverse Events That Are Related to and Caused by Feraccru® definitely related	1 Participants	—
Adverse Events That Are Related to and Caused by Feraccru® probably related	7 Participants	—
Adverse Events That Are Related to and Caused by Feraccru® possibly related	9 Participants	—

SECONDARY outcome

Timeframe: Baseline

Population: Each discontinuation reason is exclusive per patient. Some patients had multiple reason for discontinuation.

Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=34 individual reasons Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Reason for Discontinuing Each Prior Oral Ferrous Product Lack of efficacy	8 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Treatment completion	4 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Constipation	1 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Flatulence	1 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Abdominal pain	3 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Unable to tolerate	3 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Dramatically worsened GI symptoms	1 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Diarrhoea	4 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Nausea	3 individual reasons	—
Reason for Discontinuing Each Prior Oral Ferrous Product Not known	6 individual reasons	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Sex of patient at Baseline - Male or Female

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Sex of Patient at Baseline Male	21 Participants	—
Sex of Patient at Baseline Female	38 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=59 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) Chron's Disease	28 Participants	—
Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) Ulcerative Colitis (UC)	28 Participants	—
Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) Unspecified IBD	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Mean platelets count at baseline

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=56 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Platelets Count at Baseline	370.7 cells*10^9/L Standard Deviation 131.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Subjects with available B12 measurement at Baseline.

Vitamin B12 mean value at baseline

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=23 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Vitamin B12 Value at Baseline	354.6 pmol/L Standard Deviation 266.7	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Subjects with available CRP value at Baseline

Mean value of C-reactive protein (CRP) at Baseline

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=41 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Mean Corpuscular Volume at Baseline	11.9 mg/L Standard Deviation 18.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: 53 patients had MCH measured at Baseline.

Mean corpuscular haemoglobin (MCH) at Baseline

Outcome measures

Outcome measures
Measure	Normalised Hb at 12 Weeks n=53 Participants Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.	Not Normalised Hb at 12 Weeks Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.
Mean Corpuscular Hb at Baseline	27.0 pg/cell Standard Deviation 8.3	—

Adverse Events

Number of Eligible Subjects

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Number of Eligible Subjects n=59 participants at risk Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
Infections and infestations Right side buccal space abscess;	1.7% 1/59 • Number of events 1 • Baseline to approximately 12 weeks (permitting 10-16 weeks)
Gastrointestinal disorders Lower abdominal abscess	1.7% 1/59 • Number of events 1 • Baseline to approximately 12 weeks (permitting 10-16 weeks)
Blood and lymphatic system disorders Patient commenced with HB of 7.2	1.7% 1/59 • Number of events 1 • Baseline to approximately 12 weeks (permitting 10-16 weeks)
Gastrointestinal disorders gastritis and abdominal pain	1.7% 1/59 • Number of events 1 • Baseline to approximately 12 weeks (permitting 10-16 weeks)

Other adverse events

Other adverse events
Measure	Number of Eligible Subjects n=59 participants at risk Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.
Gastrointestinal disorders Diarrhoea	10.2% 6/59 • Number of events 6 • Baseline to approximately 12 weeks (permitting 10-16 weeks)
Gastrointestinal disorders Constipation	5.1% 3/59 • Number of events 3 • Baseline to approximately 12 weeks (permitting 10-16 weeks)

Additional Information

Jackie Mitchell MA DPhil

Shield TX (UK) Limited

Phone: +44 (0) 191 511 8515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER