Trial Details

Not Recruiting
Basic Information
Clinical ID c3238
Identifier EUCTR2011-001593-25-AT
Trial 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
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Inflammatory bowel disease subjects with iron deficiency anaemia MedDRA version: 16.1_Level: PT_Classification code 10021972_Term: Inflammatory bowel disease_System Organ Class: 10017947 - Gastrointestinal disorders_ MedDRA version: 16.1_Level: PT_Classification code 10022972_Term: Iron deficiency anaemia_System Organ Class: 10005329 - Blood and lymphatic system disorders_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Trade Name: MonoFer Product Name: Monofer Product Code: B03AC06 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Iron isomaltoside complex - Iron Isomaltoside 1000 CAS Number: 9004-66-4 Current Sponsor code: N.A. Other descriptive name: Iron Isomaltoside 1000 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100-
Participant Information
Sponsor Pharmacosmos A/S
City -
Country/Region Hungary;Austria
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -