Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
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|ClinicalTrials.gov Identifier: NCT01900197|
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : March 2, 2016
|Condition or disease||Intervention/treatment|
|Iron Deficiency Anemia||Drug: 10% Iron Isomaltoside 1000|
The total duration of the study is approximately 21 months, which includes a 6 months enrolment period. The number of patient visits depends on the number of Monofer® treatment courses needed during the study period. Each patient can receive one or more treatment courses during 12 months after informed consent. The last blood test will be taken after the last Monofer® treatment course which might occur 13-15 months after Informed consent. Patients will only attend hospital visits planned as part of their standard treatment and they will receive treatment as a part of standard care and according to the doctor's discretion. Study termination will occur once the 12 months observational period has been completed for all patients and the last blood test has been collected from the last Monofer® treated patient in the study. Each treatment course can consist of one or more Monofer® administrations. For each administration of Monofer® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the Monofer® treatment course.
- Clinical data management will be performed in accordance with applicable standards and data cleaning procedures.
- The collected data will systematically be entered into an eCRF (MyEDC, Biostata). The source of information is the relevant laboratory results obtained from the patient record.
- The data will be evaluated by the Pharmacosmos A/S Medical Affairs team.
Laboratory assessments, i.e. anemia work-up/treatment evaluation, shall be a part of local standard practice. The protocol does not accept any additional samples outside current local standard practice to be taken.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||391 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Iron deficiency anemia
Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (Monofer®) as standard treatment according to current practice
Drug: 10% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion
Other Name: Monofer®
- Time to relapse of iron deficiency anemia [ Time Frame: From screening until 12 months ]
- Number of ADRs [ Time Frame: From screening until 12 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): NCT01900197