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The aim of this study is to assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'Héma®. The onset of action is defined as the time required for a mean increase of at least 0,5g/dL from baseline in the haemoglobin level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tot'hema | Experimental | three ampoules per day during 12 weeks daily dose: 150mg of iron per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOT'HEMA | Drug | three ampoules per day during 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time required for a mean increase of at least 0,5g/dL from baseline in the haemoglobin level in patients with moderate IDA and daily treated with Tot'héma. | Identification of the first time (in days) associated with a mean increase in the haemoglobin level of at least 0.5 g/dL (versus mean haemoglobin level at D0). | 12 weeks |
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Inclusion Criteria:
6. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates
Non-inclusion Criteria:
Selection criterion 1. Patient with moderate anaemia defined as 8 g/dL ≤ haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before screening visit
Inclusion criteria
1. Adult men and women (≥18 years) 2. Patient with a confirmation of moderate anaemia defined as 8 g/dL ≤ haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before inclusion visit 3. Patient with ferritin blood level < lower limit of laboratory standard for this biological parameter on the last hematological test performed within 7 days before inclusion visit 4. Patient who has read, understood, dated and signed the informed consent form 5. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates Non-inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41277915 | Derived | Cacoub P, Otieno FO, Trichereau J, Gobert O, Kerveillant AL, Escola J, Verriere F. Early Haematologic Response to Oral Iron Treatment in Adults With Moderate Iron-Deficiency Anaemia. Anemia. 2025 Nov 20;2025:8866390. doi: 10.1155/anem/8866390. eCollection 2025. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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