A Phase 4 interventional study of TOT'HEMA in Anemia, sponsored by Laboratoire Innotech International. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Laboratoire Innotech International · Phase 4, Interventional, and Treatment
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 167 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Laboratoire Innotech International is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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
three ampoules per day during 12 weeks daily dose: 150mg of iron per day.
Drug: TOT'HEMA
three ampoules per day during 12 weeks
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).
Time frame: 12 weeks
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Laboratoire Innotech International