Severe Postpartum HaemorrhagePhase 3PP-02NCT01895205
Treatment of Women After Severe Postpartum Haemorrhage
A Phase 3 study testing Iron isomaltoside 1000 and Red blood cell transfusion in people with Severe Postpartum Haemorrhage, run by Pharmacosmos A/S at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Postpartum Haemorrhage
- What is being tested?
- Iron isomaltoside 1000 and Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Iron isomaltoside 1000, Red blood cell transfusion
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside 1000Drug
Also called Monofer®
Red blood cell transfusionDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fatigue
Measured: From exposure to 12 weeks post-exposure
Secondary outcomes (11)
Change in Hb concentration
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-ferritin
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Fatigue symptoms
Measured: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Postpartum depression
Measured: From week 1 to 3, 8 and 12
Breastfeeding
Measured: From exposure to 12 weeks post-exposure
Number of adverse drug reactions (ADRs)
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-iron
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-transferrin
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in transferrin saturation (TSAT)
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in reticulocyte count
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change mean reticulocyte haemoglobin content (CHr)
Measured: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Postpartum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895205
- Sponsor's protocol ID
- PP-02
- Acronym
- PP-02
- Status last verified
- Aug 2015
- First submitted
- 26 Jun 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01895205
- Acronym / sponsor ID
- PP-02 / PP-02
- Conditions
- Severe Postpartum Haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside 1000 | Experimental | Drug: Iron isomaltoside 1000A 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. |
| Red blood cell transfusion | Active comparator | Drug: Red blood cell transfusionAllogenic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron isomaltoside 1000Also: Monofer® | Drug | Iron isomaltoside 1000 |
| Red blood cell transfusion | Drug | Red blood cell transfusion |
Primary outcome
Physical Fatigue
Time frame: From exposure to 12 weeks post-exposure
11 secondary outcomes
Change in Hb concentration
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-ferritin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Fatigue symptoms
Time frame: from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Postpartum depression
Time frame: From week 1 to 3, 8 and 12
Breastfeeding
Time frame: From exposure to 12 weeks post-exposure
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
Change in p-iron
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in p-transferrin
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in transferrin saturation (TSAT)
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
Change in reticulocyte count
Time frame: From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron isomaltoside 1000 and Red blood cell transfusion in people with Severe Postpartum Haemorrhage, run by Pharmacosmos A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Fatigue (time frame: From exposure to 12 weeks post-exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.