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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Pharmacosmos A/S
Sponsor:
Collaborator:
BioStata
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01895205
First received: June 26, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Severe Postpartum Haemorrhage
Drug: Iron isomaltoside 1000
Drug: Red blood cell transfusion
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Physical Fatigue [ Time Frame: From exposure to 12 weeks post-exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Change in p-ferritin [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Fatigue symptoms [ Time Frame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Postpartum depression [ Time Frame: From week 1 to 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Breastfeeding [ Time Frame: From exposure to 12 weeks post-exposure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in p-iron [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Change in p-transferrin [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Change in transferrin saturation (TSAT) [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • Change in reticulocyte count [ Time Frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in anaemia symptoms [ Time Frame: From Baseline to week 12 ] [ Designated as safety issue: Yes ]
  • Change in gastrointestinal symptoms [ Time Frame: From Baseline to week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895205

Contacts
Contact: Lars Lykke Thomsen +45 59 48 59 59 LLT@Pharmacosmos.com

Locations
Denmark
Recruiting
Copenhagen, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
BioStata
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01895205     History of Changes
Other Study ID Numbers: PP-02
Study First Received: June 26, 2013
Last Updated: April 28, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Obstetric Labor Complications
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Ferric Compounds
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 29, 2014