Copenhagen, Denmark
NCT Number: NCT01895205
Treatment of Women After Severe Postpartum Haemorrhage
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- PPH > 1000 mL
- Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L)
- Willingness to participate and signed the informed consent form
Exclusion criteria
- Women aged < 18 years
- Multiple births
- Peripartum RBC transfusion
- Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- Women with a history of active asthma within the last 5 years or a history of multiple allergies
- Known decompensated liver cirrhosis and active hepatitis
- Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
- Active acute infection assessed by clinical judgement
- Rheumatoid arthritis with symptoms or signs of active joint inflammation
- History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- Not able to read, speak and understand the Danish language
- Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- 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
Treatment and study plan
Iron Isomaltoside 1000
DrugOther names: Monofer®
Red blood cell transfusion
DrugPrimary outcomes
-
Physical Fatigue
Time frame: From exposure to 12 weeks post-exposure
Secondary outcomes
-
Change in Hb concentration
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change in p-ferritin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Fatigue symptoms
Time frame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Postpartum depression
Time frame: From week 1 to 3, 8 and 12
-
Breastfeeding
Time frame: From exposure to 12 weeks post-exposure
-
Number of adverse drug reactions (ADRs)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change in p-iron
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change in p-transferrin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change in transferrin saturation (TSAT)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change in reticulocyte count
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
-
Change mean reticulocyte haemoglobin content (CHr)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Other outcomes
-
Change in anaemia symptoms
Time frame: From Baseline to week 12
-
Change in gastrointestinal symptoms
Time frame: From Baseline to week 12
Sponsors and collaborators
Lead sponsor
Pharmacosmos A/S
Industry
Collaborators
- BioStata
Registry information
Official study 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
Acronym: PP-02
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 10, 2013
- Registry last updated
- Aug 19, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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