Treatment of Women After Severe Postpartum Haemorrhage

NCT01895205 | Completed Phase 3

• 1 other identifier: PP-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Physical Fatigue

  From exposure to 12 weeks post-exposure

Secondary Outcomes (11)

• 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

Other Outcomes (2)

• Change in anaemia symptoms

  From Baseline to week 12

• Change in gastrointestinal symptoms

  From Baseline to week 12

Study Arms (2)

Iron isomaltoside 1000

EXPERIMENTAL

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

Red blood cell transfusion

ACTIVE COMPARATOR

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

Interventions

Iron isomaltoside 1000 DRUG

Also known as: Monofer®

Iron isomaltoside 1000

Red blood cell transfusion DRUG

Red blood cell transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• BioStata: collaborator

Study Sites (1)

Unknown Facility

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

iron isomaltoside 1000; Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

DK (1)