An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

PHASE3CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

January 9, 2017

Primary Completion Date

June 12, 2018

Study Completion Date

June 12, 2018

Conditions
Iron Deficiency AnemiaIron Deficiency Anaemia
Interventions
DRUG

Iron isomaltoside/ferric derisomaltose

"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion."

Trial Locations (22)

33012

Pharmacosmos Investigational Site, Hialeah

33014

Pharmacosmos Investigational Site, Miami Lakes

33135

Pharmacosmos Investigational Site, Miami

33147

Pharmacosmos Investigational Site, Miami

33165

Pharmacosmos Investigational Site, Miami

33172

Pharmacosmos Investigational Site, Doral

33409

Pharmacosmos Investigational Site, West Palm Beach

37404

Pharmacosmos Investigational Site, Chattanooga

70006

Pharmacosmos Investigational Site, Metairie

70125

Pharmacosmos Investigational Site, New Orleans

70808

Pharmacosmos Investigational Site, Baton Rouge

71101

Pharmacosmos Investigational Site, Shreveport

77030

Pharmacosmos Investigational Site, Houston

78215

Pharmacosmos Investigational Site 1, San Antonio

Pharmacosmos Investigational Site 2, San Antonio

87109

Pharmacosmos Investigational Site, Albuquerque

91324

Pharmacosmos Investigational Site, Northridge

91910

Pharmacosmos Investigational Site, Chula Vista

91942

Pharmacosmos Investigational Site 1, La Mesa

Pharmacosmos Investigational Site 2, La Mesa

93257

Pharmacosmos Investigational Site, Porterville

08536

Pharmacosmos Investigational Site, Plainsboro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY