NCT01900197

Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)

A Non-intervention Trial of the Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.

Detailed description

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. DATA COLLECTION: * 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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	10% Iron Isomaltoside 1000	Administered according to local routines and product labeling in doses at the doctors discretion

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-07-16
• Last updated: 2016-03-02

Locations

1 site across 1 country: Denmark