Trial Details

Not Recruiting
Basic Information
Clinical ID c2993
Identifier EUCTR2015-002496-26-DE
Trial Title A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease - ST10 versus IV iron for IDA in IBD
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Iron deficiency anaemia with inflammatory bowel disease _ MedDRA version: 20.0_ Level: LLT_ Classification code 10002062_ Term: Anaemia iron deficiency_ System Organ Class: 10005329 - Blood and lymphatic system disorders_ _ MedDRA version: 20.0_ Level: PT_ Classification code 10022972_ Term: Iron deficiency anaemia_ System Organ Class: 10005329 - Blood and lymphatic system disorders_ ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Interventions Trade Name: Feraccru Product Name: Ferracru Product Code: ST10 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ferric maltol CAS Number: 33725-54-1 Current Sponsor code: ST10-021 Other descriptive name: ferric trimaltol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Trade Name: Ferinject 50 mg Eisen/ml Product Name: Ferinject 50 mg Eisen/ml Product Code: ferric carboxymaltose Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Current Sponsor code: Ferinject 50 mg Eisen/ml Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
Participant Information
Sponsor Shield TX (UK) Ltd.
City -
Country/Region France;United States;Hungary;Belgium;Spain;Germany
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -