Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia (FAST)

Laboratoire INNOTECH

Status and phase

Completed

Phase 4

Conditions

Anemia

Treatments

Drug: TOT'HEMA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04309669

TOT401-19

Details and patient eligibility

About

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.

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Adult men and women (>18 years)
Patient with a confirmation of moderate anemia defined as: 8 g/dL ≤ Haemoglobin level ≤ 9 g/dL on the last hematological test performed within 7 days before inclusion visit.
Patient with ferritin blood level < lower limit of laboratory standard for this biological parameter at on the last hematological test performed within 7 days before inclusion visit.
Patient who has read, understood, dated and signed the informed consent form
Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates

Non-inclusion Criteria:

Patient for whose an oral iron supplementation is not indicated or not recommended according to PI's opinion
CRP > 10 mg/L on the last hematological test performed within 7 days before inclusion visit.
Patient with benign or malignant neoplastic tumour
Patient presenting gastrointestinal disorders incompatible with study treatment compliance
Pregnant or breastfeeding woman
Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception - per investigator's judgment
Patient with surgery scheduled to occur during the treatment period
Patient allergic or hypersensitive to any of the components of Tot'Héma® ampoule
Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism
Patient with active digestive bleeding (such as digestive ulcer)
Patient having taken iron supplementation, iron-based IV therapy or mineral supplementation with iron, within the 15 days prior to the inclusion visit (V2)
Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency
Patient with acute malaria crisis within 15 days prior to inclusion
Patient with a positive Faecal Occult Blood Test (FOBT)
Patient with HIV infection
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.

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

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
Patient for whom an oral iron supplementation is not indicated or not recommended according to Investigator's opinion
C-Reactive Protein > 10 mg/L on the last hematological test performed within 7 days before inclusion visit
Patient with benign or malignant neoplastic tumour
Patient presenting gastrointestinal disorders incompatible with study treatment compliance
Pregnant or breastfeeding woman
Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception - per investigator's judgment
Patient with surgery scheduled to occur during the treatment period
Patient allergic or hypersensitive to any of the components of Tot'héma® ampoule
Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism
Patient with active digestive bleeding (such as digestive ulcer)
Patient having taken iron supplementation, iron-based IV therapy mineral supplementation with iron within the 15 days prior to the inclusion visit (V2)
Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency
Patient with acute malaria crisis within 15 days prior to inclusion
Patient with a positive Faecal Occult Blood Test (FOBT)
Patient with HIV infection
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.
Patient with a family relationship to a person at the investigator's site or at the Sponsor or at the CRO.
Participant involved in another interventional or observational clinical trial or who participated in another interventional clinical trial within four weeks before inclusion.