Trial Details
Not RecruitingBasic Information
| Clinical ID | c2805 |
|---|---|
| Identifier | EUCTR2017-002452-87-GB |
| Trial Title | A randomized, double-blinded, comparative trial comparing the incidence of hypophosphatemia in relation to repeated treatment courses of iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease - hypophosphatemia following IV iron therapy in IDA due to IBD |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Iron deficiency anaemia due to inflammatory bowel disease MedDRA version: 20.0_Level: LLT_Classification code 10002062_Term: Anaemia iron deficiency_System Organ Class: 100000004851_;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] |
| Interventions | Trade Name: Monofer 100mg/ml Product Name: Monofer 100mg/ml Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Ferric derisomaltose CAS Number: 0994-66-4 Current Sponsor code: Iron oligosaccharide complex Other descriptive name: IRON(III) ISOMALTOSIDE 1000 Concentration unit: IU/mg international unit(s)/milligram Concentration type: up to Concentration number: 2000- Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: ferric carboxymaltose CAS Number: 9007-72-1 Current Sponsor code: Iron complex ferric carboxymaltose Other descriptive name: Iron trivalent Concentration unit: IU/mg international unit(s)/milligram Concentration type: up to Concentration number: 2000- |
Participant Information
| Sponsor | Pharmacosmos A/S |
|---|---|
| City | - |
| Country/Region | Austria;Denmark;Germany;United Kingdom;Sweden |
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 | - |