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Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

Anemia Clinical Trial

Official title:
Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia

Clinical Trial Summary

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

Clinical Trial Description

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03013439
Study type Interventional
Source Pharmacosmos A/S
Contact
Status Completed
Phase Phase 1
Start date January 6, 2017
Completion date June 4, 2017
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