EUCTR2018-002473-21-DE进行中（未招募）1 期
An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study) - HITSOVA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 508
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
- All
入选标准
- •At the time of enrolment subjects are eligible to be included in the study only if all of the following criteria apply:
- •1.Signed written informed consent by the subject, or if the subject is unable to do so, then consent will be sought from a family member, or a legally accepted representative as per local regulations
- •2.Males or females aged =2 weeks
- •3.Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of at least 30% between day 4 and 14 of the start of heparin exposure or at Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis.
- •4.Have adequate renal function: Glomerular filtration rate = 15 mL/min
- •5.Male participants:
- •A male participant must agree to use contraception during the treatment period and for at least 5 days after the last dose of study intervention and refrain from donating sperm during this period.
- •6.Female participants:
- •A female participant is eligible to participate if 1 of the following conditions applies:
- •a.Not a woman of childbearing potential
- •b.A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days corresponding to time needed to eliminate study intervention. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for = 3 months prior to entry into the study.)
- •7.Understanding/willingness by the subject or his/her legally accepted representative to participate in the clinical study and ability to comply with study procedures and the study visit schedule
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 486
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •At the time of enrolment subjects are excluded from the study if any of the following criteria apply:
- •1.Premature infants (corrected age <37 weeks gestational age)
- •2.Expectation of cardiac surgery within the next 44 days
- •3.Life expectancy clearly less than the 44 days
- •4.Recent fibrinolytic therapy since the start of heparin therapy leading to the target indication for enrolment, HIT
- •5.Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
- •6.Severe hepatic impairment (Child-Pugh Class C)
- •7.Active bleeding
- •8. Subjects with:
- •(i)Severe hemorrhagic diathesis,
- •(ii)Severe kidney insufficiency,
- •(iii)Damage to the central nervous system or brain,
- •(iv)Spinal or ophthalmologic surgery are to be excluded if alternative
- •antithrombotic treatments are available.
- •(v)Active stomach/duodenal ulcers or active peptic ulcer unless this
- •ulcer is the cause of the surgical procedure
- •9.An unexplained activated partial thromboplastin time (aPTT) > 2 x the
- •normal range
- •10. Any cerebrovascular accident within the previous 3 months or has a history of haemorrhagic cerebrovascular incidence
- •11.Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg
- •12.Diabetic retinopathy
- •13.Acute bacterial endocarditis
- •14.Expectation of a long-term (> 3 weeks) haemodialysis requirement before the end of the acute treatment
- •15.Hypersensitivity to the active substances or to any of the excipients
- •16.Hypersensitivity to sulphite
- •17.Any investigational drug(s) use within 4 weeks preceding Screening or anticipated use during the course of the study
- •18.Pregnant or breastfeeding woman
- •19.Use of intra-aortic balloon pump, or ventricular assist device
研究者
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