Treatment of women after severe Postpartum Haemorrhage

• Conditions: Severe postpartum anaemia; MedDRA version: 16.0Level: PTClassification code 10036417Term: Postpartum haemorrhageSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2012-005783-10-DK
• Lead Sponsor: Pharmacosmos A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

A subject will be eligible for inclusion in the study if they fulfil the following criteria:
1.PPH > 1000 mL
2.Hb = 5.5 and = 8.0 g/dL (= 3.5 and = 5.0 mmol/L)
3.Willingness to participate and signed the informed 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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject will NOT be eligible for inclusion in this study if they fulfil any of the following criteria:
1.Women aged < 18 years
2.Multiple births
3.Peripartum RBC transfusion
4.Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
5.Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
6.Women with a history of active asthma within the last 5 years or a history of multiple allergies
7.Known decompensated liver cirrhosis or active hepatitis
8.Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syn-drome (defined according to Dansk Selskab for Obstetrik og Gynækologi guidelines)
9.Active acute infection assessed by clinical judgement
10.Rheumatoid arthritis with symptoms or signs of active joint inflammation
11.History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
12.Not able to read, speak and understand the Danish language
13.Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
14.Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus

Study & Design

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