Iron deficiency anaemia in pregnant woman MedDRA version: 14.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Ferinject
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferric carboxymaltose (FCM)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5
Sponsors
Vifor Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged =18, gestational week =16, =33 at baseline visit with normal antenatal screening test results. 2. Serum ferritin =20 mcg/L and iron deficiency anaemia defined as Hb concentration =8 g/dL and =10.4 g/dL during gestational weeks 16 to 26 or =11.0 g/dL during gestational weeks 27 to 33, at screening. 3. Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study. 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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study. 2. Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia. 3. Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dL or outside reference range), any acute infection at screening. 4. Pre-eclampsia. 5. Multiple pregnancy. 6. Evidence on any significant abnormalities on anomaly ultrasound. 7. Haemochromatosis or other iron storage disorders. 8. Folate deficiency (S-folate <4.5 nmol/L) at screening. 9. Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening. 10. Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study. 11. Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula). 12. Severe cardiovascular diseases. 13. Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection. 14. Inability to fully comprehend and/or perform study procedures in the Investigator’s opinion. 15. History of endocrine disorders. 16. Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia. 17. Recent significant bleeding/surgery (within the 3 months prior to screening). 18. Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening. 19. Participation in any other interventional study since estimated conception and throughout study participation. 20. Known hypersensitivity to FCM or other IV iron preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective • To evaluate the efficacy of FCM compared to oral iron in the treatment of iron deficiency anaemia (IDA) in pregnant women of the second and third trimester.;Secondary Objective: Secondary Objective(s) • To evaluate the safety and tolerability of FCM and oral iron in pregnant women with IDA. • To assess the safety of the treatment with FCM on the newborn child. • To determine the relationship between changes in iron status and the effects on the quality of life (QoL).;Primary end point(s): 1. Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority). ;Timepoint(s) of evaluation of this end point: 1. Week 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in Hb from baseline at Weeks 6, 9, 12 and at delivery. 2. Change in other iron/haematological parameters (serum ferritin, transferrin saturation, serum iron, blood reticulocyte Hb content, etc.) from baseline at Weeks 3, 6, 9 and 12 and at delivery. 3. Proportion of subjects with an Hb correction to level of at least 11 g/dL (anaemia correction) by delivery. 4. Time to anaemia correction (Hb =11 g/dL). 5. Change in health-related QoL at Week 3 and at last visit before delivery using the SF-36. 6. Patient global assessment score at Weeks 3, 6, 9 and 12 and at delivery.;Timepoint(s) of evaluation of this end point: 1. Week 6, Week 9, Week 12, & at Delivery 2. Week 3, Week 6, Week 9, Week 12, & at Delivery 3. Delivery 4. Each visit 5. Week 3, & last visit before delivery 6. Week 3, Week 6, Week 9, Week 12, & at Delivery | — |
Countries
Germany, Korea, Republic of, Russian Federation, Saudi Arabia, Sweden, Switzerland, Turkey
Contacts
Public ContactMedical Information
Vifor Pharma
Outcome results
None listed