Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease

Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks studies there is a need to follow-up on long term safety and efficacy of any maintenance iron therapy.

This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside 1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).

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Key information

Conditions

Inflammatory Bowel Disease Anaemia Anemia Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
Life expectancy beyond 18 months by Investigator's judgement.
Willingness to participate after informed consent. -

Exclusion criteria

Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
Any major protocol deviation in Lead-in Study.
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].
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.
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.

Treatment and study plan

MonoFer

Drug

Infusion according to current HB level

Primary outcomes

Long term efficacy

Time frame: Baseline to month 12
- 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.
- 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 outcomes

Long term safety

Time frame: Baseline to month 12

To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance, measured through laboratory testings and number of subjects who experience any adverse drug reaction.

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 5, 2011
Registry last updated: Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed