Treatment of Women After Postpartum Haemorrhage

Postpartum Haemorrhage Clinical Trial

— PP-01  

Official title:

A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895218
• Other study ID #: PP-01
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: April 28, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion 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

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 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, unstable ischaemic heart disease or uncontrolled diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Iron isomaltoside 1000
A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.

Other:
• Standard medical Care
Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacosmos A/S	BioStata

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in anaemia symptoms		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	Yes
Other	Change in gastrointestinal symptoms		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	Yes
Primary	Physical fatigue	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.	From exposure to 12 weeks post-exposure	No
Secondary	Change in Hb concentration		From exposure to week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in concentrations of p-ferritin		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in Fatigue symptoms		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in postpartum depression symptoms		From exposure to 12 weeks post-exposure	No
Secondary	Breastfeeding		From exposure to 12 weeks post-exposure	No
Secondary	RCB transfusions		From exposure to 12 weeks post-exposure	No
Secondary	Adverse drug reactions (ADRs)		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	Yes
Secondary	Change in concentrations of p-iron		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in concentrations of p-transferrin		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in concentrations of transferrin saturation (TSAT)		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in concentrations of reticulocyte count		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in concentrations of mean reticulocyte haemoglobin content (CHr)		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	No
Secondary	Change in haematology parameters		From exposure to day 3, week 1, 3, 8 and 12 post-exposure	Yes