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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410435
• Other study ID #: P-Monofer-IBD-01-Extension
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2011
• Last updated: November 25, 2013
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im Gesundsheitswesen
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Monofer
Infusion according to current HB level

Locations

Country	Name	City	State
Austria	Austria	Austria
Hungary	Hungary	Hungary

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacosmos A/S

Countries where clinical trial is conducted

Austria,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term efficacy	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.	Baseline to month 12	No
Secondary	Long term safety	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.	Baseline to month 12	Yes