Trial Details

Not Recruiting
Basic Information
Clinical ID c2314
Identifier EUCTR2022-000894-16-NL
Trial Title Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease_ - PRIme
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory Bowel Disease MedDRA version: 20.0_Level: PT_Classification code 10022972_Term: Iron deficiency anaemia_System Organ Class: 10005329 - Blood and lymphatic system disorders_ MedDRA version: 20.0_Level: PT_Classification code 10022970_Term: Iron deficiency_System Organ Class: 10027433 - Metabolism and nutrition disorders_ MedDRA version: 20.1_Level: PT_Classification code 10021972_Term: Inflammatory bowel disease_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Trade Name: Feraccru Pharmaceutical Form: Capsule, hard INN or Proposed INN: FERRIC MALTOL CAS Number: 33725-54-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Trade Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Ferrofumaraat TEVA Pharmaceutical Form: Tablet INN or Proposed INN: Ferrous fumarate CAS Number: 141-01-5 Other descriptive name: FERROUS FUMARATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Monofer Pharmaceutical Form: Solution for infusion INN or Proposed INN: Ferric derisomaltose CAS Number: 9004-66-04 Other descriptive name: IRON(III) ISOMALTOSIDE 1000 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Trade Name: Cosmofer Product Name: iron(III)-hydroxide dextran complex Product Code: Cosmofer Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: CosmoFer CAS Number: 9004-66-4 Other descriptive name: IRON(III)-HYDROXIDE DEXTRAN COMPLEX Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Venofer Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Venofer CAS Number: 8047-67-4 Other descriptive name: IRON SUCROSE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
Participant Information
Sponsor Leiden University Medical Center
City -
Country/Region Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -