Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioStata | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to monitor and quality assure the efficacy and safety of MonoferĀ® in a broad patient population when MonoferĀ® is used according to the MonoferĀ® label (SPC) in current practice and where standard routines are being followed.
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 MonoferĀ® 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 MonoferĀ® 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 MonoferĀ® treated patient in the study. Each treatment course can consist of one or more MonoferĀ® administrations. For each administration of MonoferĀ® either intravenous infusion or injection can be used. Pre- and post-treatment blood tests according to standard treatment are a part of the MonoferĀ® treatment course.
DATA COLLECTION:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron deficiency anemia | Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (MonoferĀ®) as standard treatment according to current practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% Iron Isomaltoside 1000 | Drug | Administered according to local routines and product labeling in doses at the doctors discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse of iron deficiency anemia | From screening until 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ADRs | From screening until 12 months |
Not provided
Inclusion Criteria:
Patients with iron deficiency anemia treated on the doctor's discretion with MonoferĀ® as standard treatment according to current practice
Exclusion Criteria:
None
Not provided
Not provided
Not provided
Not provided
Patients with iron deficiency anemia treated on the doctor's dicretion with MonoferĀ® as standard treatment according to current practice
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29213281 | Derived | Frigstad SO, Haaber A, Bajor A, Fallingborg J, Hammarlund P, Bonderup OK, Blom H, Rannem T, Hellstrom PM. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |