Severe postpartum anaemia MedDRA version: 16.0 Level: PT Classification code 10036417 Term: Postpartum haemorrhage System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue.;Secondary Objective: The secondary efficacy objectives of the study are to evaluate the effect of iron isomaltoside 1000 compared to RBC transfusion on • Ability to increase Hb • Other relevant iron and RBC related biochemical parameters • Other fatigue symptoms • Symptoms of postpartum depression. • Time of postpartum lactogenesis • Time of discontinuation of breastfeeding The safety objectives of the study are to evaluate the safety of iron isomaltoside 1000 com-pared to RBC transfusion by • Adverse events (AEs) • Vital signs • Biochemical safety parameters Other objectives • Maternal milk iron level • Anaemia and gastrointestinal symptoms ;Primary end point(s): The primary endpoint of the study is to measure and compare the aggregated change in phys-ical fatigue score from baseline to week 12 (area under the curve (AUC)) in the two treatment arms measured by the Multidimensional Fatigue Inventory (MFI).;Timepoint(s) of evaluation of this end point: From baseline till week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are to measure and compare the following in the two treatment arms • Change in Hb concentration from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 • Proportion of women who achieve Hb levels of > 10 g/dL (6.2 mmol/L) at any time • Proportion of women who achieve increase from baseline in Hb concentration = 2.0 g/dL (1.2 mmol/L) at any time • Change in concentrations of p-ferritin, p-iron, p-transferrin, transferrin saturation (TSAT), reticulocyte count and mean reticulocyte haemoglobin content (CHr) from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 • Change in MFI physical fatigue symptoms from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 • Change in other MFI fatigue symptoms from day 3 to week 1, 3, 8 and 12 • Change in fatigue symptoms measured by the postpartum questionnaire from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 • Change in postpartum depression symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) from week 1 to 3, 8 and 12 • Time to postpartum lactogenesis • Time to discontinuation of breastfeeding ;Timepoint(s) of evaluation of this end point: Please see secondary endpoints for timepoints. | — |
Countries
Denmark
Contacts
Public ContactClinical R & D
Pharmacosmos A/S
Outcome results
None listed