Back to resultsTreatment of Women After Severe Postpartum Haemorrhage (PP-02)
Primary Purpose
Severe Postpartum Haemorrhage
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Iron isomaltoside 1000
Red blood cell transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Severe Postpartum Haemorrhage
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iron isomaltoside 1000
Red blood cell transfusion
Arm Description
A single dose of 1500 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9% sodium chloride and given over approximately 15 min.
Allogenic RBC transfusion is dosed to trigger Hb: Women with Hb 5.5 - 6.4 g/dL (3.5-3.9 mmol/L) will receive 2 units of RBC Women with Hb 6.5 - 8.0 g/dL (4.0-5.0 mmol/L) will receive 1 unit of RBC
Outcomes
Primary Outcome Measures
Physical Fatigue
Secondary Outcome Measures
Change in Hb concentration
Change in p-ferritin
Fatigue symptoms
Postpartum depression
Breastfeeding
Number of adverse drug reactions (ADRs)
Change in p-iron
Change in p-transferrin
Change in transferrin saturation (TSAT)
Change in reticulocyte count
Change mean reticulocyte haemoglobin content (CHr)
Full Information
NCT ID
NCT01895205
First Posted
June 26, 2013
Last Updated
August 18, 2015
Sponsor
Pharmacosmos A/S
Collaborators
BioStata
1. Study Identification
Unique Protocol Identification Number
NCT01895205
Brief Title
Treatment of Women After Severe Postpartum Haemorrhage
Acronym
PP-02
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
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacosmos A/S
Collaborators
BioStata
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Postpartum Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron isomaltoside 1000
Arm Type
Experimental
Arm Description
A single dose of 1500 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9% sodium chloride and given over approximately 15 min.
Arm Title
Red blood cell transfusion
Arm Type
Active Comparator
Arm Description
Allogenic RBC transfusion is dosed to trigger Hb:
Women with Hb 5.5 - 6.4 g/dL (3.5-3.9 mmol/L) will receive 2 units of RBC
Women with Hb 6.5 - 8.0 g/dL (4.0-5.0 mmol/L) will receive 1 unit of RBC
Intervention Type
Drug
Intervention Name(s)
Iron isomaltoside 1000
Other Intervention Name(s)
Monofer®
Intervention Type
Drug
Intervention Name(s)
Red blood cell transfusion
Primary Outcome Measure Information:
Title
Physical Fatigue
Time Frame
From exposure to 12 weeks post-exposure
Secondary Outcome Measure Information:
Title
Change in Hb concentration
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Change in p-ferritin
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Fatigue symptoms
Time Frame
from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Postpartum depression
Time Frame
From week 1 to 3, 8 and 12
Title
Breastfeeding
Time Frame
From exposure to 12 weeks post-exposure
Title
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
Title
Change in p-iron
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Change in p-transferrin
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Change in transferrin saturation (TSAT)
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
Change in reticulocyte count
Time Frame
From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Title
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 Pre-specified Outcome Measures:
Title
Change in anaemia symptoms
Time Frame
From Baseline to week 12
Title
Change in gastrointestinal symptoms
Time Frame
From Baseline to week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Women After Severe Postpartum Haemorrhage
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