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

NCT01410435 | Completed Phase 3 DMC

• 1 other identifier: P-Monofer-IBD-01-Extension
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 2

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).

Conditions

Inflammatory Bowel Disease; Anaemia

Outcome Measures

Primary Outcomes (1)

• Long term efficacy

  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.

  Baseline to month 12

Secondary Outcomes (1)

• Long term safety

  Baseline to month 12

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Monofer

Interventions

Monofer DRUG

Infusion according to current HB level

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (2)

Austria

Austria, Austria

Location

Hungary

Hungary, Hungary

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anemia

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: August 5, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

AU (1); HU (1)