This long-term follow-up study will assess the ability to maintain a stable haemoglobin (iron containing molecule in the blood) and safety profile of iron isomaltoside 1000 (Monofer®) in Inflammatory Bowel Disease subjects with iron deficiency anemia.

An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001593-25-AT

Enrollment

Registered

2011-04-28

Start date

2011-06-08

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease subjects with iron deficiency anaemia MedDRA version: 16.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 16.1 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: MonoFer Product Name: Monofer Product Code: B03AC06 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Iron isomaltoside complex - Iron Isomaltoside 1000 CAS Number: 9004-66-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron. 2. Life expectancy beyond 18 months by Investigator’s judgement. 3. Willingness to participate after informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Discontinuation from Lead-in Study (except for due to intolerance to oral therapy). 2. Any major protocol deviation in Lead-in Study. 3. Pregnancy and nursing [To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches]. 4. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. 5. Patients with a Harvey-Bradshaw Index > 8 or Partial Mayo Score (excluding Endoscopy Sub-score) > 6 at End of Study Visit of Lead-in Study.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb = 12.0 g/dL) in subjects with Hb = 12.0 g/dL at the Baseline of Extension Study. 2. To assess the ability to achieve stable Hb (Hb = 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study. ;Secondary Objective: 1. To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance. 2. To assess the dosage and frequency of additional iron isomaltoside 1000 (Monofer®), if administered. 3. To assess the change in other relevant biochemical parameters (serum iron, serum ferritin, Total Iron Binding Capacity and Transferrin Saturation). 4. To assess Quality of Life (QoL) by Inflammatory Bowel Disease Questionnaire (IBDQ). 5. To assess the change in Restless Leg Syndrome (RLS) score by Cambridge-Hopkins RLS questionnaire (CH-RLSq) in subjects with RLS symptoms in Lead-in Study. 6. To assess disease activity status using Harvey-Bradshaw Index for Crohn’s Disease or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis. 7. To assess the change in platelet count. ;Primary end point(s): 1. Number of subjects (with Hb = 12.0 g/dL at the Baseline of Extension Study) who maintain stable Hb (defined as Hb = 12.0 g/dL) at all visits of the Extension Study. 2. Number of subjects (with Hb = 12.0 g/dL at Month 3 Visit of Extension Study) who maintain stable Hb (defined as Hb = 12.0 g/dL) at all visits from Month 3 Visit of Extension Study in subjects with Hb < 12.0 g/dL at Baseline of Extension Study. ;Timepoint(s) of evaluation of this end point: Month 3, 6, 9, 12 Visit	—

Measure

Time frame

Main Objective: 1. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb = 12.0 g/dL) in subjects with Hb = 12.0 g/dL at the Baseline of Extension Study. 2. To assess the ability to achieve stable Hb (Hb = 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study. ;Secondary Objective: 1. To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance. 2. To assess the dosage and frequency of additional iron isomaltoside 1000 (Monofer®), if administered. 3. To assess the change in other relevant biochemical parameters (serum iron, serum ferritin, Total Iron Binding Capacity and Transferrin Saturation). 4. To assess Quality of Life (QoL) by Inflammatory Bowel Disease Questionnaire (IBDQ). 5. To assess the change in Restless Leg Syndrome (RLS) score by Cambridge-Hopkins RLS questionnaire (CH-RLSq) in subjects with RLS symptoms in Lead-in Study. 6. To assess disease activity status using Harvey-Bradshaw Index for Crohn’s Disease or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis. 7. To assess the change in platelet count. ;Primary end point(s): 1. Number of subjects (with Hb = 12.0 g/dL at the Baseline of Extension Study) who maintain stable Hb (defined as Hb = 12.0 g/dL) at all visits of the Extension Study. 2. Number of subjects (with Hb = 12.0 g/dL at Month 3 Visit of Extension Study) who maintain stable Hb (defined as Hb = 12.0 g/dL) at all visits from Month 3 Visit of Extension Study in subjects with Hb < 12.0 g/dL at Baseline of Extension Study. ;Timepoint(s) of evaluation of this end point: Month 3, 6, 9, 12 Visit

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Secondary

Measure	Time frame
Secondary end point(s): 1. Number of subjects who achieve stable Hb (Hb = 12.0 g/dL) at any single visit. 2. Number of consecutive visits for which stable Hb (Hb = 12.0 g/dL) is maintained. 3. Dosage of iron isomaltoside 1000 (Monofer®) re-administered, if required. 4. Frequency of additional dosing of iron isomaltoside 1000 (Monofer®), if required. 5. Change in concentrations of serum iron, serum ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS) from Baseline to End of Study of Extension Study. 6. Change in total QoL score (IBDQ score) from Baseline to Month 6 and End of Study of Extension Study. 7. Change in RLS symptoms by CH-RLSq score (in subjects with RLS symptoms in Lead-in Study) from Baseline to Month 6 and End of Study of Extension Study. 8. Change in disease activity status using Harvey-Bradshaw Index for Crohn’s Disease, or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis from Baseline to Month 6 and End of Study of Extension Study. 9. Number of subjects who experience any adverse drug reaction including any Suspected Unexpected Serious Adverse Event (SUSAR). 10. Number of subjects who discontinue study because of lack of response or intolerance to investigational drug. 11. Change in platelet count from Baseline to Month 6 and End of Study of Extension Study. ;Timepoint(s) of evaluation of this end point: Month 3, 6, 9, 12 Visit	—

Measure

Time frame

Secondary end point(s): 1. Number of subjects who achieve stable Hb (Hb = 12.0 g/dL) at any single visit. 2. Number of consecutive visits for which stable Hb (Hb = 12.0 g/dL) is maintained. 3. Dosage of iron isomaltoside 1000 (Monofer®) re-administered, if required. 4. Frequency of additional dosing of iron isomaltoside 1000 (Monofer®), if required. 5. Change in concentrations of serum iron, serum ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS) from Baseline to End of Study of Extension Study. 6. Change in total QoL score (IBDQ score) from Baseline to Month 6 and End of Study of Extension Study. 7. Change in RLS symptoms by CH-RLSq score (in subjects with RLS symptoms in Lead-in Study) from Baseline to Month 6 and End of Study of Extension Study. 8. Change in disease activity status using Harvey-Bradshaw Index for Crohn’s Disease, or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis from Baseline to Month 6 and End of Study of Extension Study. 9. Number of subjects who experience any adverse drug reaction including any Suspected Unexpected Serious Adverse Event (SUSAR). 10. Number of subjects who discontinue study because of lack of response or intolerance to investigational drug. 11. Change in platelet count from Baseline to Month 6 and End of Study of Extension Study. ;Timepoint(s) of evaluation of this end point: Month 3, 6, 9, 12 Visit

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Countries

Austria, Hungary

Contacts

Public ContactLene Heledie

Pharmacosmos A/S

lhe@pharmacosmos.com+4559485936

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026