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A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

NCT01895231 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-03-15

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

Conditions

  • Iron-deficiency

Interventions

DRUG

Iron isomaltoside 1000 (Monofer®)

DRUG

Placebo

Sponsors & Collaborators

  • Max Neeman

    collaborator UNKNOWN

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Nørgaard · RH Blodbanken

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895231 on ClinicalTrials.gov