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

NCT04309669 | Completed Phase 4

• 1 other identifier: TOT401-19
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia

Outcome Measures

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).

  12 weeks

Study Arms (1)

Tot'hema

EXPERIMENTAL

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

Drug: TOT'HEMA

Interventions

TOT'HEMA DRUG

three ampoules per day during 12 weeks

Tot'hema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women (\>18 years)
• 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
• Patient for whose an oral iron supplementation is not indicated or not recommended according to PI's opinion
• 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 with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency
• Patient with a positive Faecal Occult Blood Test (FOBT)
• Patient with HIV infection

Sponsors & Collaborators

• Laboratoire Innotech International: lead

Study Sites (1)

Hopital Pitié Salpétrière - Médecine Interne et Immunologie Clinique

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 41277915 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: November 12, 2020
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

FR (1)