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Completed

NCT Number: NCT01895205

Treatment of Women After Severe Postpartum Haemorrhage

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron Isomaltoside 1000

Drug

Other names: Monofer®

Red blood cell transfusion

Drug

Primary outcomes

  1. Physical Fatigue

    Time frame: From exposure to 12 weeks post-exposure

Secondary outcomes

  1. Change in Hb concentration

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  2. Change in p-ferritin

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  3. Fatigue symptoms

    Time frame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  4. Postpartum depression

    Time frame: From week 1 to 3, 8 and 12

  5. Breastfeeding

    Time frame: From exposure to 12 weeks post-exposure

  6. 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

  7. Change in p-iron

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  8. Change in p-transferrin

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  9. Change in transferrin saturation (TSAT)

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  10. Change in reticulocyte count

    Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12

  11. 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 outcomes

  1. Change in anaemia symptoms

    Time frame: From Baseline to week 12

  2. Change in gastrointestinal symptoms

    Time frame: From Baseline to week 12

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Collaborators

  • BioStata

Registry information

Official study 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

Acronym: PP-02

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2013
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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