Iron deficiency anemia MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Ferrous sulfate
CAS Number: 7720-78-7
Other descriptive name: FERROUS SULFATE
Concentration unit: mg milligram(s)
Concentration
Sponsors
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age equal to or more than 18 years 3. Written informed consent provided by the patient 4. Hb below 10g/dl, as defined by other trials 5. Absolute red blood cell (RBC) count below 4.7 x 106/mm3 for men or 4.2 x 106/mm3 for women 6. Mean corpuscular volume (MCV) of RBCs below 80 fl 7. Mean corpuscular Hb (MCH) of RBCs below 27 pg 8. Total ferritin below 30 ng/ml; this criterion is associated with sensitivity more than 99% for iron deficiency 9. In the case of patients with anemia after GI tract hemorrhage, inclusion criteria 6 and 7 DO NOT apply for study inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Age below 18 years • Denial to provide written informed consent • Acute myelogenous or lymphoblastic leukemia • Multiple myeloma • Primary or secondary myelodysplastic syndrome • Planning for start of chemotherapy within the first 30 days after inclusion in the trial • Planning for start of radiotherapy within the first 30 days after inclusion in the trial • Intake of erythropoietin • Planning for start of erythropoietin within the first 30 days after inclusion in the trial • Intake of chemotherapy the last six months • Intake of radiotherapy the last six months • Known hemochromatosis • Known celiac disease • Liver cirrhosis of Child-Pugh stage II or III • Any active overt bleeding • Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The scope of this study is to compare the efficacy of the new oral formulation of Fe-ASP to oral ferrous sulfate in patients with IDA for the restoration of decreased circulating Hb.;Secondary Objective: The improvement of symptoms of anemia, the restoration of biomarkers of iron deficiency into the normal range and the incidence of GI tract side effects.;Primary end point(s): The primary study endpoint is the comparative increase of baseline Hb in each study group after the first 4 weeks of treatment. Since the daily amount of elemental iron delivered with the ferrous sulfate regimen is 94 mg and with the Fe-ASP regimen 80 mg, the increase of baseline Hb will be adjusted per mg of delivered elemental iron.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary study endpoints will be the differences between the two groups of treatment in the following: • Normalization of Hb; this is defined as Hb=13 g/dl for mean and =12 g/dl for women • Ferritin levels at weeks 4 and 12 • Absolute reticulocyte count at weeks 1, 4 and 12 • Absolute RBC count, Hb, MCV and MCH at weeks 4 and 12 • Change of the fatigue symptoms of IDA at weeks 4 and 12 • Change of physical findings of IDA at weeks 4 and 12 • The incidence of GI side effects at weeks 4 and 12;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Outcome results
None listed