Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Hb Levels at 12 Weeks | Change in Haemoglobin levels from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Sex of Patient at Baseline | Sex of patient at Baseline - Male or Female | Baseline |
| Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) | Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Real World subjects with IBD (Crohn's disease or ulcerative colitis) who are also diagnosed with mild-moderate IDA.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton General Hospital | Southampton | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Number of Eligible Subjects | Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Number of Eligible Subjects | Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru. | Posted | Count of Participants | Participants | 12 weeks (permitting 10-16 weeks) |
|
Baseline to approximately 12 weeks (permitting 10-16 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Number of Eligible Subjects | Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right side buccal space abscess; | Infections and infestations | Non-systematic Assessment | Right side buccal space abscess; admitted to hospital and treated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | Diarrhoea |
Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jackie Mitchell MA DPhil | Shield TX (UK) Limited | +44 (0) 191 511 8515 | jmitchell@shieldtx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2017 | Aug 26, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to Week 12 (permitting 10-16 weeks) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Change in Transferrin Saturation at Week 4 | Change in transferrin saturation (TSAT) at Week 4 | Baseline to Week 4 (permitting 3 to 5 weeks) |
| Change in Transferrin Saturation at 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® | 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 | 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 from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru. | Baseline |
| Time From Diagnosis of IDA to Initiation of Feraccru® | Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru® | Baseline |
| Prior IV Treatment History | Prior intravenous iron treatment history | Baseline |
| Reason for Initiating Feraccru® | Reason(s) for initiation of Feraccru® | Baseline |
| Percentage of Patients Who Discontinue Feraccru® | Percentage of patients who discontinue Feraccru® during the 12 weeks period | Baseline to week 12 |
| Reason for Discontinuing Feraccru® | 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® | 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 | Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP. | Baseline |
| Baseline |
| Platelets Count at Baseline | Mean platelets count at baseline | Baseline |
| Vitamin B12 Value at Baseline | Vitamin B12 mean value at baseline | Baseline |
| Mean Corpuscular Volume at Baseline | Mean value of C-reactive protein (CRP) at Baseline | Baseline |
| Mean Corpuscular Hb at Baseline | Mean corpuscular haemoglobin (MCH) at Baseline | Baseline |
| Lost to Follow-up |
|
| Missing Feraccru stop date |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Haemoglobin | Mean | Standard Deviation | g/dl |
|
| Type of Inflammatory Bowel Disease | Count of Participants | Participants |
|
|
|
| Secondary | Change in Hb Levels at Week 4 | Change in Haemoglobin levels from baseline to Week 4 | Subjects with available Hb at Week 4 (permitting 3 to 5 weeks). | Posted | Mean | Standard Deviation | g/dl | 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 | Subjects with available Hb at Week 12 (permitting 10-16 weeks). | Posted | Mean | Standard Deviation | g/dl | 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. | Subjects with available Hb at Week 12 (permitting 10-16 weeks) | Posted | Mean | Standard Deviation | days | 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 | Subjects with available ferritin measurements at Week 4 (permitting 3 to 5 weeks). | Posted | Mean | Standard Deviation | ug/ml | 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 | Subjects with available ferritin measurement at Week 12 (permitting 10-16 weeks) | Posted | Mean | Standard Deviation | ug/ml | 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. | Subjects with available ferritin measurements at Week 12 (permitting 10-16 weeks). | Posted | Count of Participants | Participants | 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. | Subjects with available ferritin measurement at Week 12 (permitting 10 to 16 weeks). | Posted | Mean | Standard Deviation | days | 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 | Due to insufficient data, this outcome could not be measured. | Posted | 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 | Due to insufficient data, this outcome could not be measured. | Posted | 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%. | Due to insufficient data, this outcome could not be measured. | Posted | 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%. | Due to insufficient data, this outcome could not be measured. | Posted | 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. | Subjects with available medical history on IBD prior to Feraccru. | Posted | Mean | Standard Deviation | years | Baseline |
|
|
|
| Secondary | Time From Diagnosis of IDA to Initiation of Feraccru® | Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru® | Subjects with available medical history on IDA prior to Feraccru. | Posted | Mean | Standard Deviation | days | Baseline |
|
|
|
| Secondary | Prior IV Treatment History | Prior intravenous iron treatment history | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Reason for Initiating Feraccru® | Reason(s) for initiation of Feraccru® | The initiation reasons are not exclusive per patient. Some subjects had multiple reasons for initiating Feraccru®. | Posted | Count of Units | initiation reasons | Baseline | initiation reasons | initiation reasons |
|
|
|
| Secondary | Percentage of Patients Who Discontinue Feraccru® | Percentage of patients who discontinue Feraccru® during the 12 weeks period | Posted | Number | percentage of participants | Baseline to week 12 |
|
|
|
| Secondary | Reason for Discontinuing Feraccru® | Reasons for stopping will be collected as predefined common options and a free text field. | The categories are not mutually exclusive so a single subject could have multiple reasons listed. | Posted | Number | percentage of participants | 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® | Posted | Count of Participants | Participants | 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. | Each discontinuation reason is exclusive per patient. Some patients had multiple reason for discontinuation. | Posted | Number | individual reasons | Baseline | individual reasons | individual reasons |
|
|
|
| Other Pre-specified | Sex of Patient at Baseline | Sex of patient at Baseline - Male or Female | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis) | Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis) | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Platelets Count at Baseline | Mean platelets count at baseline | Posted | Mean | Standard Deviation | cells*10^9/L | Baseline |
|
|
|
| Other Pre-specified | Vitamin B12 Value at Baseline | Vitamin B12 mean value at baseline | Subjects with available B12 measurement at Baseline. | Posted | Mean | Standard Deviation | pmol/L | Baseline |
|
|
|
| Other Pre-specified | Mean Corpuscular Volume at Baseline | Mean value of C-reactive protein (CRP) at Baseline | Subjects with available CRP value at Baseline | Posted | Mean | Standard Deviation | mg/L | Baseline |
|
|
|
| Other Pre-specified | Mean Corpuscular Hb at Baseline | Mean corpuscular haemoglobin (MCH) at Baseline | 53 patients had MCH measured at Baseline. | Posted | Mean | Standard Deviation | pg/cell | Baseline |
|
|
|
| 0 |
| 59 |
| 1 |
| 59 |
| 9 |
| 59 |
|
| Lower abdominal abscess | Gastrointestinal disorders | Non-systematic Assessment | Lower abdominal abscess (secondary to CD) |
|
| Patient commenced with HB of 7.2 | Blood and lymphatic system disorders | Non-systematic Assessment | Patient commenced on Feraccru® with HB of 7.2 |
|
| gastritis and abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Patient admitted overnight with gastritis and abdominal pain |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Constipation |
|
Not provided
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| Title | Measurements |
|---|---|
|
| Intolerance to oral iron |
|
| Clinician decision |
|
| Not recorded |
|
| Other |
|
| Title |
|---|
| Measurements |
|---|
|
| Constipation |
|
| Treatment complete |
|
| Lack of efficacy |
|
| Nausea |
|
| Not known |
|
| Other |
|
| Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Lack of efficacy |
|
| Treatment completion |
|
| Constipation |
|
| Flatulence |
|
| Abdominal pain |
|
| Unable to tolerate |
|
| Dramatically worsened GI symptoms |
|