Postpartum haemorrhage MedDRA version: 16.1 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: A subject will be eligible for inclusion in the study if they fulfil the following criteria: 1. Women with PPH = 700 and = 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery 2. 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline 12. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 13. Not able to read, speak and understand the Danish language 14. Any other medical condition that, in the opinion of the 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, un-stable ischaemic heart disease or uncontrolled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.;Secondary Objective: The secondary efficacy objectives of the study are to evaluate the effect of iron isomaltoside 1000 compared to standard medical care 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 • Transfusion of allogenic RBCs The safety objective of the study is to evaluate the safety of iron isomaltoside 1000 compared to standard medical care by • Discontinuation due to intolerance • Adverse events (AEs) • Vitals signs • Biochemical safety parameters Other objectives • Validation of the postpartum questionnaire • Maternal milk iron level • Anaemia and gastrointestinal symptoms ;Primary end point(s): The primary endpoint of the study is to measure and compare the change in physical fatigue score from baseline to week 12 in the two treatment arms measured by the Multidimensional Fatigue Inventory (MFI);Timepoint(s) of evaluation of this end point: From baseline to 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 week 1, 3, 8 and 12 • Proportion of women who achieve or maintain 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 • Proportion of women with decrease 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 3, week 1, 3, 8 and 12 • Change in MFI physical fatigue symptoms from baseline to day 3, week 1, 3, 8 and 12 • Change in other MFI fatigue symptoms from baseline to day 3, week 1, 3, 8 and 12 • Change in postpartum depression symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) from week 1 to week 3, 8 and 12 • The amount of days from delivery to the day of postpartum lactogenesis • The amount of days from delivery to the day of discontinuation of breastfeeding • Proportion of women who has received 1 or more allogenic RBC transfusions and the number of units of RBC transfused per transfused patient during the study Safety endpoints • Proportion of women who discontinue from the study because of lack of response or intolerance of investigational drugs • Type and incidence of adverse drug reactions (ADRs) including any suspected unex-pected serious adverse events (SUSAR) • Number of AEs of special interest (i.e. hypersensitivity reactions or hypotension at pre-specified time points in relation to administration of study drug) • Change in haematology parameters, p-sodium, p-potassium, p-calcium, p-phosphate, p-urea, p-creatinine, p-albumin, p-bilirubin, Aspartate Aminotransferase (ASAT), and Alanine Aminotransferase (ALAT) from baseline to day 3, week 1, 3, 8 and 12 | — |
Countries
Denmark
Contacts
Public ContactClinical R & D
Pharmacosmos A/S
Outcome results
None listed