Clinical trial NCT01895205: Treatment of Women After Severe Postpartum Haemorrhage
Official title: A Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Red Blood Cell Transfusion in Women With Severe Postpartum Iron Deficiency Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Postpartum Haemorrhage
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
Collaborators: name: BioStata
First posted: 2013-07-10
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose 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


Eligibility criteria: Inclusion 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

Exclusion 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 and active hepatitis
8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (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

Primary outcomes:
measure: Physical Fatigue
timeFrame: From exposure to 12 weeks post-exposure
Secondary outcomes:
measure: Change in Hb concentration
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change in p-ferritin
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Fatigue symptoms
timeFrame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Postpartum depression
timeFrame: From week 1 to 3, 8 and 12
measure: Breastfeeding
timeFrame: From exposure to 12 weeks post-exposure
measure: Number of adverse drug reactions (ADRs)
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change in p-iron
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change in p-transferrin
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change in transferrin saturation (TSAT)
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change in reticulocyte count
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
measure: Change mean reticulocyte haemoglobin content (CHr)
timeFrame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Other outcomes:
measure: Change in anaemia symptoms
timeFrame: From Baseline to week 12
measure: Change in gastrointestinal symptoms
timeFrame: From Baseline to week 12
Locations:
city: Copenhagen
country: Denmark
Study officials:
References: