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

Anemia Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309669
• Other study ID #: TOT401-19
• Status: Completed
• Phase: Phase 4
• Start date: November 12, 2020
• Est. completion date: October 6, 2023

Study information

• Verified date: October 2023
• Source: Laboratoire Innotech International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• TOT'HEMA
three ampoules per day during 12 weeks

Locations

Country	Name	City	State
France	Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire Innotech International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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