Clinical Trials Logo
  1. Home
  2. Inflammatory Bowel Disease
  3. NCT01599702

Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease — IBD-02  

Inflammatory Bowel Disease Clinical Trial

Official title:
A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease (PROMISE)

Clinical Trial Summary

The study is a prospective, non-controlled, open-label multi-centre pilot safety study of iron isomaltoside 1000 (Monofer®) administered to subjects with anaemia and Inflammatory Bowel Disease (IBD). Based upon haemoglobin (Hb) level, the subjects are divided into two treatment groups, A and B. Depending on the body weight, subjects in Treatment Group A will receive a total dose of 1,500 mg or 2,000 mg IV iron isomaltoside 1000 as a single infusion, whereas subjects in Treatment Group B will receive a total dose of 2,500 mg or 3,000 mg IV iron isomaltoside 1000 divided into two administrations.

Clinical Trial Description

Subjects with a diagnosis of IBD (Crohn's disease or ulcerative colitis) and IDA ( Iron Deficiency Anaemia) with or without concomi-tant inflammation will be enrolled to receive a high dose of IV iron isomaltoside 1000. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01599702
Study type Interventional
Source Pharmacosmos A/S
Contact
Status Completed
Phase Phase 3
Start date May 2012
Completion date December 2014
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03278912 - Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT05579392 - A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis N/A
Completed NCT03264690 - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
Recruiting NCT02861053 - Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ? N/A
Recruiting NCT02275676 - Resting Energy Expenditure and Nutritional Status in IBD N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT02161640 - Vascular Dysfunction in Paediatric IBD N/A
Completed NCT01852760 - Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound N/A
Completed NCT01860651 - Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease N/A
Completed NCT01933867 - Water-aided Colonoscopy in Inflammatory Bowel Disease Patients N/A
Completed NCT01666535 - Infliximab IBD Influenza Vaccine Study N/A
Completed NCT01692743 - Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD) Phase 3
Completed NCT01688557 - Trial on Innovative Technologies in Colonoscopy N/A
Completed NCT01676324 - FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD) N/A
Completed NCT01557387 - Real-time Diagnosis of Pseudopolyps During Colonoscopy
Completed NCT01981616 - Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab Phase 1
Completed NCT01221818 - A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects Phase 1
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A