Treatment of pregnant women with iron deficiency

Phase 1

• Conditions: iron deficiency in pregnant women; MedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: LLTClassification code 10002041Term: Anaemia complicating pregnancy, childbirth, or the puerperiumSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-000776-29-DK
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-22
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.Women aged =18 years
2.Pregnancy at GA 14+0 - 21+0
3.Ferritin <30 µg/L (0-29 µg/L) after 4 weeks of standard treatment in a clinical setting
4.Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
2.Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
3.Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
4.Known hypersensitivity to any excipients in the investigational drug products
5.History of active asthma within the last 5 years
6.History of multiple allergies
7.Known decompensated liver cirrhosis or active hepatitis
8.Active acute or chronic infections (assessed by clinical judgement)
9.Rheumatoid arthritis with symptoms or signs of active inflammation
10.Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
11.Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
12.Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
13.Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
14.Meeting RBC-transfusion criteria (Hb =6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb = 6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
15.Multiple pregnancies
16.Inability to read and understand the Danish language

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified