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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01410435
First received: July 6, 2011
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Inflammatory Bowel Disease
Anaemia
 Drug: Monofer
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Long term efficacy [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]
    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:
  • Long term safety [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Monofer
Infusion according to current HB level

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

    -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410435

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

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01410435     History of Changes
Other Study ID Numbers: P-Monofer-IBD-01-Extension
Study First Received: July 6, 2011
Last Updated: November 22, 2012
Health Authority: Austria: Bundesamt für Sicherheit im Gesundsheitswesen

Additional relevant MeSH terms:
Anemia
Inflammatory Bowel Diseases
Intestinal Diseases
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013