Trial Details
Not RecruitingBasic Information
| Clinical ID | c3060 |
|---|---|
| Identifier | EUCTR2014-001518-25-DE |
| Trial Title | A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer) against Placebo in Subjects with Iron Deficiency Anaemia and who are Intolerant or Unresponsive to Oral Iron Therapy |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Subjects with iron deficiency anaemia (IDA) caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy. MedDRA version: 17.1_Level: PT_Classification code 10022972_Term: Iron deficiency anaemia_System Organ Class: 10005329 - Blood and lymphatic system disorders_;Therapeutic area: Not possible to specify |
| Interventions | Trade Name: Monofer Pharmaceutical Form: Solution for injection INN or Proposed INN: Iron Isomaltoside 1000 CAS Number: 1370654-58-2 Other descriptive name: IRON ISOMALTOSIDE 1000 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: -100 Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use |
Participant Information
| Sponsor | Pharmacosmos A/S |
|---|---|
| City | - |
| Country/Region | United States;Russia;Germany;United Kingdom |
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 | - |