Iron deficiency among pregnant women. MedDRA version: 9.1 Level: LLT Classification code 10022972 Term: Iron deficiency anaemia
Conditions
Interventions
Product Name: Maltofer® Fol Film-Coated Tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Iron(III)-Hydrixide Polymaltose Complex 100mg and Folic acid 0.4mg
Trade Name: Plastufer®
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients of 18 years and above with iron deficiency anaemia (haemoglobin [Hb] =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Iron overload (e.g., haemochromatosis, haemosiderosis). • Disturbances in iron utilisation (e.g., lead anaemia, sidero achrestic anaemia, thalassaemia). • Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia). • Anaemia related to blood loss, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia. • Known hypersensitivity to iron polymaltose complex film-coated tablets (Maltofer® Fol film-coated tablets) or to iron sulphate or to any excipients. • Participation in another clinical study during the study and 4 weeks prior to the study. • Preeclampsia. • Acute infectious diseases, parasitosis. • Tested positive for human immunodeficiency virus (HIV) or hepatitis B surface (HBs) antigen as confirmed by prior assessment at beginning of pregnancy (if prior assessments are not available, tests for HIV and HBs have to be performed at screening). • History of alcohol or drug abuse. • Non-responder to oral iron products. • Severe diseases of liver, kidney, cardiovascular system, gastrointestinal tract, psychological disorders and other which in the investigator’s opinion makes participation in study unacceptable. • Intake of iron-containing preparations (including multi-vitamin preparations containing iron), 14 days prior to the first dosing day or intake of iron-containing preparations other than the study medication during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is the evaluation of the efficacy and tolerability of Maltofer® Fol film-coated tablets compared to a generic iron sulphate compound in iron-deficient pregnant women.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is defined as the change in Hb from baseline to end of treatment on Day 90 in both treatment groups. The primary safety endpoint is defined as the number of adverse events/reactions observed during the study period in all treatment groups. | — |
Countries
Bulgaria, Estonia, Latvia, Lithuania
Outcome results
None listed