Iron Deficiency Anaemia
Conditions
Interventions
Product Code: V0305
Pharmaceutical Form: Oral solution
CAS Number: 7782-63-0
Current Sponsor code: V0305
Other descriptive name: FERROUS SULFATE HEPTAHYDRATE
Concentration unit: millilitre(s)/gram
Con
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female and male child, - Child aged between 6 months to 53 months (inclusive), - 7.0 kg =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to pathologies: - Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure, - Haemochromatosis or iron overload of secondary origin (blood transfusion), - Presence of gastro duodenal ulcer, - Inflammatory bowel disease or any digestive disease which could modify iron absorption, - Child presenting any clinically significant condition (abnormality on physical examination or laboratory test results) which, in the opinion of the investigator, could interfere with the interpretation of study data, or which otherwise contraindicates participation in the study, - Child suffering from Pica syndrome. Related to treatments: - Oral or parenteral iron treatment within 3 weeks prior to V1 - Child with a history of hypersensitivity to at least one of the components of the tested products, including fructose intolerance (due to sorbitol excipient), - Child with a history of intolerance to oral iron derivatives, - Child needing a long term treatment known to modify iron absorption. Others: - Child being a family member or a child of a work associate (secretary, nurse, technician) of the investigator, - Child participation in another clinical trial, - Child in exclusion period in another clinical trial, having received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial, - Parent(s) or guardian(s) linguistically or psychologically not able to understand the protocol or to comply with its requirements or to attend to visits, - Child and parent(s) or guardian(s) unlikely to be compliant during the study according to the judgment of the Investigator, - Parent(s)/guardian(s) not able to be reached by phone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Month 3 (V4, Day 90 ± 7 days);Main Objective: To document the effect of V0305 administered during 3 months (princeps period) on the blood haemoglobin level in children with IDA .;Primary end point(s): Blood haemoglobin level at Month 3 (V4, Day 90 ± 7 days);Secondary Objective: - To document the effect of V0305 administered during 6 months (the princeps 3-month period then a second period of 3 additional months) on the blood haemoglobin level in children with IDA . - To document the effect of V0305 administered during 3 months then 3 additional months on the serum ferritin level (restoration of iron stores) in children with IDA - To assess the acceptability of the formulation by the parent(s)/guardian(s) and the global satisfaction regarding the treatment and the ease of adaptation of the dose by the investigator at the end of the study. - To document the tolerance of V0305 administered during 3 to 6 months in children with IDA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For all subjects: - Month 3 (V4, Day 90 ± 7 days), - Week 3 (V3, Day 21 +/- 2 days). For subjects without a normalisation of both blood haemoglobin and serum ferritin levels at Month 3(V4), who are treated up to Month 6 : Month 6 (V5, Day 180 ± 7 ).;Secondary end point(s): For all subjects: - Haemoglobin responder criterion at Month 3 (V4, Day 90 ± 7 days) defined by a normalisation of blood haemoglobin level (blood haemoglobin level > or = to 110 g/L), - Serum ferritin level at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days), - Ferritin responder criterion at Month 3(V4, Day 90 ± 7 days) defined by a normalisation of serum ferritin level (serum ferritin level > or = to 12 µg/L); - Combined responder criterion, defined by a normalisation of both blood haemoglobin and serum ferritin levels at Month 3 (V4, Day 90 ± 7 days), - Haemoglobin level and reticulocytes count at Week 3 (V3, Day 21 ± 2 days), - Acceptability of this formulation assessed by the parent(s)/guardian(s) (questionnaire) at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days), - Evaluation by the investigator of the global satisfaction regarding the treatment at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days), - Evaluation by the investigator of the ease of adaptation of the dose (questionnaire) at Week 3 (V3, Day 21 ± 2 days), Month 3 (V4, Day 90 ± 7 days). For subjects without a normalisation of both blood haemoglobin and serum ferritin levels at Month 3(V4), who are treated up to Month 6 : - Blood haemoglobin level and serum ferritin level at Month 6 (V5, Day 180 ± 7 days), - Haemoglobin responder criterion at Month 6 (V5, Day 180 ± 7 days) defined by a normalisation of blood haemoglobin level, - Ferritin responder criterion at Month 6 (V5, Day 180 ± 7 days) defined by a normalisation of serum ferritin level, - Combined responder criterion, defined by a normalisation of blood haemoglobin and serum ferritin levels at | — |
Countries
Poland
Contacts
Public ContactClinical Study Manager A.Stennevin
Institut de Recherche Pierre Fabre
Outcome results
None listed