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

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ClinicalTrials.gov Identifier: NCT01410435
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Anaemia Drug: Monofer Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Drug: Monofer
Infusion according to current HB level



Primary Outcome Measures :
  1. Long term efficacy [ Time Frame: Baseline to month 12 ]
    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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410435


Locations
Austria
Austria
Austria, Austria
Hungary
Hungary
Hungary, Hungary
Sponsors and Collaborators
Pharmacosmos A/S

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01410435     History of Changes
Other Study ID Numbers: P-Monofer-IBD-01-Extension
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Ferric Compounds
Hematinics