An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside (Monofer®) (FerWonExt)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02962648|
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron-Deficiency Anemia||Drug: Iron Isomaltoside||Phase 3|
Among the various formulations of parenteral iron available on the market, iron isomaltoside may allow flexibility in terms of high and rapid dosing. The use of parenteral iron, especially in high doses, may result in better compliance, fewer visits to the medical practitioner, and overall improvement in QoL.
Most trials with IV iron have been 4-12 weeks trials and long-term trials are warranted to fol-low-up on long-term safety.
This trial is a 6-months extension trial where the aim is to evaluate the safety and efficacy of IV iron isomaltoside re-dosing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside (Monofer®)|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||June 12, 2018|
|Actual Study Completion Date :||June 12, 2018|
Experimental: Iron isomaltoside
Drug: Iron Isomaltoside
Other Name: Monofer
- The primary outcome measure is the number of adverse drug reaction (ADR). [ Time Frame: 6 months ]
- Change in Hb [ Time Frame: 6 months ]
- Protocol defined cardiovascular adverse events (number of participants with such events) [ Time Frame: 6 months ]
- Change in Ferritin [ Time Frame: 6 months ]
- Change in Transferrin saturation (%) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962648
|United States, Florida|
|Miami, Florida, United States|