EUCTR2020-004692-40-IT进行中（未招募）1 期
An Exploratory, Open label, Randomized, Parallel-Group, Pilot Study to evaluate Safety, Tolerability and Efficacy of daily, subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4 weeks, in pregnant women who are diagnosed with pre-eclampsia between the 26th and 32nd weeks of gestation. - PPL20
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Dilafor AB
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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