Treatment of Women After Severe Postpartum Haemorrhage

Severe Postpartum Haemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895205
• Other study ID #: PP-02
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: August 18, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: August 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Severe Postpartum Haemorrhage

Intervention

Drug:
• Iron isomaltoside 1000

• Red blood cell transfusion

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 Baseline to week 12	Yes
Other	Change in gastrointestinal symptoms		From Baseline to week 12	Yes
Primary	Physical Fatigue		From exposure to 12 weeks post-exposure	No
Secondary	Change in Hb concentration		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Change in p-ferritin		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Fatigue symptoms		from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Postpartum depression		From week 1 to 3, 8 and 12	No
Secondary	Breastfeeding		From exposure to 12 weeks post-exposure	No
Secondary	Number of adverse drug reactions (ADRs)		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	Yes
Secondary	Change in p-iron		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Change in p-transferrin		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Change in transferrin saturation (TSAT)		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Change in reticulocyte count		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No
Secondary	Change mean reticulocyte haemoglobin content (CHr)		From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12	No