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| Name | Class |
|---|---|
| BioStata | INDUSTRY |
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The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside 1000 | Experimental | A single dose of 1500 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9% sodium chloride and given over approximately 15 min. |
|
| Red blood cell transfusion | Active Comparator | Allogenic RBC transfusion is dosed to trigger Hb:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside 1000 | Drug |
|
| |
| Red blood cell transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Fatigue | From exposure to 12 weeks post-exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 | |
| Change in p-ferritin | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anaemia symptoms | From Baseline to week 12 | |
| Change in gastrointestinal symptoms | From Baseline to week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Drug |
|
| Fatigue symptoms |
| from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Postpartum depression | From week 1 to 3, 8 and 12 |
| Breastfeeding | From exposure to 12 weeks post-exposure |
| Number of adverse drug reactions (ADRs) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in p-iron | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in p-transferrin | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in transferrin saturation (TSAT) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change in reticulocyte count | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| Change mean reticulocyte haemoglobin content (CHr) | From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |