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

Phase 1

• Conditions: Inflammatory bowel disease subjects with iron deficiency anaemia; MedDRA version: 14.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-001593-25-HU
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-27
• Study Completion: 2013-07-11
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified