Assessment of the eFficacy, the Onset-of-Action and the Safety of Tot’héma® in adults with moderate iron deficiency anaemia


Start:                     November 2020

Status:                  Enrolling

Design:                 Clinical Trial

Study Sites:        UNIM Research and Training Centre

Sponsor:             Laboratoire Innotech International  

IRB:                        Jaramogi Oginga Odinga Teaching and Referral Hospital Ethical Review IERC/JOOTRH/293/20

Purpose:              The purpose of the study sponsored by Laboratoire INNOTECH INTERNATIONAL is to investigate the time course of the increase in Hb level and other parameters associated with IDA at the very early stages of treatment (3rd, 5th, 7th days) to assess the Onset-of-Action of an Iron gluconate liquid formulation (Tot’héma®).

Design:                 This is an international (Zone I: Kenya – Zone II: Europe), open-label, multicentre, prospective, non-comparative study evaluating the onset of action and the safety of Tot’héma® in the treatment of IDA. The study will have approximately 15 to 20 sites in Europe and Kenya to recruit 121 eligible patients. The Kenyan sites will be expected to recruit half of the patients competitively with each site expected to recruit approximately 30 patients. The study schedule includes 5 visits and 11 blood samplings. Visits consist of 1 screening visit (Visit 1/D-7 to D-1), 1 inclusion (baseline) visit (Visit 2/D0), 2 follow-up visits (Visit 3/D14 and Visit 4/D28), and 1 End-of-Study visit (Visit 5/D84). Blood sampling will be performed during the screening period, between D-7 and D-1, at D0, D3, D5, D7, D10, D14, D21, D28, D56 and D84.

Population:        The study will recruit from the general population patients with moderate anaemia defined as haemoglobin level of 8.0 g/dl to 10.0 g/dL (all values inclusive) on the last haematological test performed within 7 days before screening visit.

Study Size:          Approximately 121 Adult men and women (≥18 years) with iron deficiency anaemia will be enrolled.

Study Aims:        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 0.5 g/dL from baseline in haemoglobin level.