Treatment of Women After Severe Postpartum Haemorrhage (PP-02)

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

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

Study Overview

• Status: Completed
• Conditions: Severe Postpartum Haemorrhage
• Intervention / Treatment: Drug: Red blood cell transfusion; Drug: Iron isomaltoside 1000

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron isomaltoside 1000; 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.	Drug: Iron isomaltoside 1000; Other Names: Monofer®
Active Comparator: Red blood cell transfusion; 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	Drug: Red blood cell transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical Fatigue	From exposure to 12 weeks post-exposure

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Hb concentration	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-ferritin	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Fatigue symptoms	from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Postpartum depression	From week 1 to 3, 8 and 12
Breastfeeding	From exposure to 12 weeks post-exposure
Number of adverse drug reactions (ADRs)	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-iron	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-transferrin	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in transferrin saturation (TSAT)	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in reticulocyte count	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change mean reticulocyte haemoglobin content (CHr)	From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

Other Outcome Measures

Outcome Measure	Time Frame
Change in anaemia symptoms	From Baseline to week 12
Change in gastrointestinal symptoms	From Baseline to week 12

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Collaborators: BioStata

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: July 4, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2015
• Last Update Submitted That Met QC Criteria: August 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: PP-02