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CompletedNCT04309669FASTUpdated Oct 23, 2023

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
167
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Anemia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
  1. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Tot'hema

    three ampoules per day during 12 weeks daily dose: 150mg of iron per day.

    Drug: TOT'HEMA

Interventions

  • DrugTOT'HEMA

    three ampoules per day during 12 weeks

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04309669
Lead sponsor
Laboratoire Innotech International
Responsible party
Sponsor
First posted
Mar 16, 2020
Start date
Nov 12, 2020
Primary completion
Oct 6, 2023
Completion
Oct 6, 2023
Last update
Oct 23, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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