AnemiaPhase 4FASTNCT04309669
Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia
A Phase 4 study testing TOT'HEMA in people with Anemia, run by Laboratoire Innotech International at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- TOT'HEMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2020to 6 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 6. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates
- Non-inclusion Criteria:
Show all 42Show fewer
- 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
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique
Paris, 75013
About this study
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.
- Conditions
- Anemia
- Being tested
- TOT'HEMA
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOT'HEMADrug
three ampoules per day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tot'hema | Experimental | three ampoules per day during 12 weeks daily dose: 150mg of iron per day. Receives: Drug: TOT'HEMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start12 Nov 2020
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Innotech International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309669
- Sponsor's protocol ID
- TOT401-19
- Acronym
- FAST
- Status last verified
- Oct 2023
- First submitted
- 9 Mar 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cacoub P, Otieno FO, Trichereau J, Gobert O, Kerveillant AL, Escola J, Verriere F. Early Haematologic Response to Oral Iron Treatment in Adults With Moderate Iron-Deficiency Anaemia. Anemia. 2025 Nov 20;2025:8866390. doi: 10.1155/anem/8866390. eCollection 2025.
PubMed 41277915
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot'héma® in Adults With Moderate Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT04309669
- Acronym / sponsor ID
- FAST / TOT401-19
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Laboratoire Innotech InternationalIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tot'hema | Experimental | Drug: TOT'HEMAthree ampoules per day during 12 weeks daily dose: 150mg of iron per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- 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
- 6. Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOT'HEMAthree ampoules per day during 12 weeks | Drug | Tot'hema |
Primary outcome
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.
Time frame: 12 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41277915Cacoub P, Otieno FO, Trichereau J, Gobert O, Kerveillant AL, Escola J, Verriere F. Early Haematologic Response to Oral Iron Treatment in Adults With Moderate Iron-Deficiency Anaemia. Anemia. 2025 Nov 20;2025:8866390. doi: 10.1155/anem/8866390. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TOT'HEMA in people with Anemia, run by Laboratoire Innotech International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.