Moderate iron deficiency anaemia MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851
Conditions
Sponsors
Laboratoire Innotech Internationnal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criterion 1. Patient with moderate anaemia defined as 8 g/dL = haemoglobin level = 10 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 = 10 g/dL on the last hematological test performed within 7 days before inclusion visit 3. Patient with ferritin blood level =65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: 1. Patient for whom an oral iron supplementation is not indicated or not recommended according to Investigator’s opinion 2. C-Reactive Protein > 10 mg/L on the last hematological test performed within 7 days before inclusion visit 3. Patient with malignant neoplastic tumour 4. Patient presenting gastrointestinal disorders incompatible with study treatment compliance 5. Pregnant or breastfeeding woman 6. Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception – per investigator’s judgment 7. Patient with surgery scheduled to occur during the treatment period 8. Patient allergic or hypersensitive to any of the components of Tot'héma® ampoule 9. Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism 10. Patient with active digestive bleeding (such as digestive ulcer) 11. Patient having taken iron supplementation, iron-based IV therapy or mineral supplementation with iron within the 15 days prior to the inclusion visit (V2) 12. Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency 13. Patient with acute malaria crisis within 15 days prior to inclusion 14. Patient with a positive Faecal Occult Blood Test (FOBT) 15. Patient with HIV infection 16. Unreliable patients, including non-observant patients, patients with known alcoholism or drug abuse, or with a history of a serious psychiatric disorder, as well as patients who are reluctant to give informed consent or to comply with protocol requirement. 17. Patient with a family relationship to a person at the investigator’s site or at the Sponsor or at the CRO. 18. Participant involved in another interventional or observational clinical trial or who participated in another interventional clinical trial within four weeks before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 0.5 g/dL from baseline in the haemoglobin level.;Secondary Objective: Assessment in patients with moderate IDA treated with Tot'héma: -of the Onset-of-Action of Tot'héma, defined as the time required for a mean increase of at least 0.5g/dL from baseline in the haemoglobin (Hb) level, in each of the 2 geographic zones -of the Onset-of-Action of Tot'héma®, defined as the time required for a mean increase of at least 2 g/dL from baseline in the Hb level -of the proportion of patients achieving different levels of improvement and a normalization of Hb level -of the time course of the increase and the normalization of Hb level -of the evolution of biological markers of anaemia -of the evolution of the mean level of C CRP -of the evolution of fatigue in patients -of the evolution of quality of life of patients -performance of conjunctival pallor for detecting mIDA and its evolution during treatment -of patient compliance with treatment -of treatment safety -of the overall level of investigators’ satisfaction with the treatment;Primary end point(s): First time (in days) associated with a mean increase of the haemoglobin level of at least 0.5 g/dL (versus mean haemoglobin level at D0). This primary endpoint will be assessed by modelling the evolution during the treatment of the mean haemoglobin level between Day 0 and Week 12;Timepoint(s) of evaluation of this end point: Day0 (baseline), Day3, Day5, Day7, Day10, Day14, Day21, Day28, Day56, Day84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •First time (in days) associated with an increase in the mean haemoglobin level of at least 0.5 g/dL in patients of each geographic zone (versus mean haemoglobin level at baseline in Europe and Kenya) (Cf primary endpoint) •First time (in days) associated with an increase in the mean haemoglobin level of at least 2 g/dL (versus mean haemoglobin level at baseline) •Percentage of patients presenting an increase in Hb level = 0.5g/dL (vs. baseline - D0) at each scheduled sampling time point •Percentage of patients presenting an increase in Hb level = 1 g/dL (vs. baseline - D0) at each scheduled sampling time point •Percentage of patients presenting an increase in Hb level = 2 g/dL (vs. baseline - D0) at each scheduled sampling time point •Percentage of patients with a normalization of Hb levels at each scheduled sampling time point (Hb = 12 g/dL for women, Hb = 13 g/dL for men) •Time to onset (in days) of a 0.5 g/dL increase in haemoglobin level (vs. baseline - D0) •Time to onset (in days) of a 1 g/dL increase in haemoglobin level (vs. baseline - D0) •Time to onset (in days) of a 2 g/dL increase in haemoglobin level (vs. baseline - D0) •Time (in days) to normalization of haemoglobin levels (Hb = 12 g/dL in women and Hb = 13 g/dL in men) •Mean haemoglobin level at each scheduled sampling time point and its evolution during treatment compared to baseline (D0) •Mean reticulocytes level at each scheduled sampling time point and its evolution during treatment compared to baseline (D0) •Mean levels of other relevant biological markers assayed at scheduled sampling time point (ferritin blood level, MCV, serum iron, T-SAT) and their evolution during treatment compared to baseline (D0) •Mean CRP level at each scheduled sampling time point and its evolution during treatment compared to baseline (D0) •Patient’s fatigue assessed by a Visual Analogue Scale (VAS) and by the FACIT-fatigue questionnaire, and its evolution during treatment compared to patient’ | — |
Countries
Bulgaria, France, Kenya
Contacts
Public ContactClinical Trials information
ICTA PM
Outcome results
None listed