- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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®)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aalborg, Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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Administered according to local routines and product labeling in doses at the doctors discretion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to relapse of iron deficiency anemia
Time Frame: From screening until 12 months
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From screening until 12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of ADRs
Time Frame: From screening until 12 months
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From screening until 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Monofer®-NIS-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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