E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anaemia in pregnant woman |
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E.1.1.1 | Medical condition in easily understood language |
Iron deficiency anaemia in pregnant woman |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022972 |
E.1.2 | Term | Iron deficiency anaemia |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Korea, Republic of |
Russian Federation |
Saudi Arabia |
Switzerland |
Turkey |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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At approximately 20 weeks (depending on gestation period) all final assessments of mother and child post-delivery, will be completed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |