Preeclampsia diagnosed at week 26-32 of gestation. MedDRA version: 20.0 Level: LLT Classification code 10040444 Term: Severe pre-eclampsia System Organ Class: 100000004868
Conditions
Interventions
Product Name: Tafoxiparin
Product Code: [DF01]
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: TAFOXIPARIN SODIUM
CAS Number: 1638190-65-4
Current Sponsor code: DF01
C
Sponsors
Dilafor AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Nulliparous pregnant women of =18 and = 45 years of age ii) The subject has been diagnosed with pre-eclampsia defined as: Hypertension 160/100 mmHg with proteinuria (= 2+ on urine dip-stick) or albumin/creatinine = 30 mg/mmol iii) The subject is planned for hospitalization iv) Gestational age = 26th and = 32nd weeks confirmed by ultrasound before 21st weeks of gestation v) Singleton pregnancy vi) Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls vii) Subject can understand and sign an informed consent form viii) Provision of written informed consent 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 23 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Subjects who are unable to understand the written and verbal instructions in local language ii) Presence of placenta previa iii) Pathologic CTG at inclusion iv) Diagnosed with Diabetes type1 v) Presence of eclampsia vi) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets) vii) Previously known coagulation disorders (Leiden – heterozygote; OK) viii) Current use of any drugs that interfere with hemostasis (including heparin /LMWH, oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.) ix) Diagnosed with Essential hypertension with ongoing therapy x) Diagnosed with HIV or Acute hepatitis with ongoing therapy xi) Known history of allergy to standard heparin and/or LMWH heparin xii) History of heparin-induced thrombocytopenia (platelet count = 100.000) xiii) Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study. xiv) Subjects that are not fit for participation in the study according to the opinion of the investigator due to a concurrent disease or severe organ affection xv) Current participation in other interventional medicinal treatment studies xvi) Subject has a fear of needles which is believed by the Investigator to affect study medication compliance xvii) Severe pulmonary edema xviii) Idiopathic thrombocytopenia xix) Diagnosed with chronic kidney disease xx) Diagnosed with chronic hepatic disorders xxi) Diagnosed with systemic lupus erythematosus xxii) Diagnosed with antiphosphlipid syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the maternal and neonatal safety, tolerability and feasibility of subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4 weeks, in pregnant women who develop pre-eclampsia between the 26th and 32nd weeks of gestation.;Secondary Objective: To assess the efficacy of tafoxiparin treatment on preeclampsia.;Primary end point(s): Safety and tolerability will be evaluated through the frequency and character of adverse events and serious adverse events, complete and symptom-directed physical evaluations, vital signs, safety blood samples (hematology and clinical chemistry) and rate of withdrawals from the study and/or from the study medication.;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) Change in diastolic blood pressure from baseline to end of treatment and at 8 weeks follow-up control ii) Change in Aortic Pulse Wave Velocity (PWV) measured by carotid–femoral PWV (cfPWV) at baseline, after 2, 7 and 28 days of treatment, and at 8 weeks follow-up control iii) Change in cardiac output iv) Change in soluble Fms-like tyrosine kinase 1 (sFlt-1) v) Change in Placental Growth Factor (PlGF) vi) Change in sFlt-1/PlGF ratio vii) Days of maintained pregnancy viii) Extent of anti-hypertensive treatment (number of drugs and doses) ix) Fetal growth changes estimated by ultrasound x) Change in umbilical cord blood flow xi) Change in uterine artery BLOOD FLOW xii) Proportion of subjects with abruptio placenta xiii) Proportion of infants with birth weight =5th percentile xiv) Proportion of infants with birthweight in 6th - 10th percentile xv) Proportion of subjects with fetal loss after 28 weeks of gestation xvi) Proportion of subjects with eclampsia xvii) Proportion of subjects with oliguria xviii) Proportion of subjects submitted to ICU during the study xix) Proportion of subjects undergoing preterm delivery xx) Proportion of subjects undergoing caesarean sections (CS) xxi) Maternal and fetal Indications for CS xxii) Proportion of subjects undergoing instrumental deliveries (vacuum extraction (VE)/forceps delivery) xxiii) Proportion of subjects with Postpartum Hemorrhage (PPH) > 2000 ml xxiv) Fetal outcome measured as Birth weight, Apgar score, Acidosis (pH<7.10) and/or Base Excess < -12 mmol/L arterial or venous in umbilical cord blood xxv) Indication for referral to NICU.;Timepoint(s) of evaluation of this end point: From start of treatment until 8 weeks after discharge. | — |
Countries
Italy
Contacts
Public ContactCEO
Dilafor AB
Outcome results
None listed