EUCTR2012-005782-12-DKActive, not recruitingNot Applicable
A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose Infusions or Standard Medical Care in Women after Postpartum Haemorrhage - P-Monofer-PP-01
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Pharmacosmos A/S
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •A subject will be eligible for inclusion in the study if they fulfil the following criteria:
- •1.Women with PPH = 700 and = 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
- •2.Willingness to participate and signed the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •A subject will NOT be eligible for inclusion in this study if they fulfil any of the following 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 or active hepatitis
- •8.Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syn-drome (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.Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- •12.History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- •13.Not able to read, speak and understand the Danish language
- •14.Any other medical condition that, in the opinion of the 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, un-stable ischaemic heart disease or uncontrolled diabetes mellitus
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Treatment of women after severe Postpartum HaemorrhageSevere postpartum anaemiaMedDRA version: 16.0Level: PTClassification code 10036417Term: Postpartum haemorrhageSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsEUCTR2012-005783-10-DKPharmacosmos A/S20
Completed
Not Applicable
An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotensioCardiovascular surgery which used cardiopulmonary bypassJPRN-UMIN000016290Wakayama Medical University Department of Anesthesiology30
Active, not recruiting
Phase 1
A Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancerMedDRA version: 20.0 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 100000004864Ovarian cancerEUCTR2012-004808-34-PLJanssen-Cilag International NV576
Active, not recruiting
Phase 1
A Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancerOvarian cancerEUCTR2012-004808-34-GBJanssen-Cilag International NV576
Recruiting
Unknown
A Non-Randomized, Open-Label, Comparative Study of Skin Care Instruction by Health Care Professionals Using Cosmetics for Healthy PeopleJPRN-UMIN000052080univesity of tokyo40