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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: TOT'HEMA

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Information Medicale; Phone Number: +33 (0) 1 46 15 18 00; Email: INFORMATION.VIGILANCE@innothera.com

Study Locations

• France
  • Paris, France, 75013
    • Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult men and women (>18 years)
2. 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.
3. 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.
4. Patient who has read, understood, dated and signed the informed consent form

6. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates

Non-inclusion Criteria:

1. Patient for whose an oral iron supplementation is not indicated or not recommended according to PI's opinion
2. CRP > 10 mg/L on the last hematological test performed within 7 days before inclusion visit.
3. Patient with benign or 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.

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

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 benign or 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tot'hema; three ampoules per day during 12 weeks daily dose: 150mg of iron per day.	Drug: TOT'HEMA; three ampoules per day during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Laboratoire Innotech International

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies
• Other Study ID Numbers: TOT401-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No