EUCTR2010-019375-30-DE进行中（未招募）不适用
A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ablynx
- 入组人数
- 115
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
- •1. 18 years of age or older (adults) or aged 12 to < 18 years (adolescents)
- •2. Men or female willing to accept an acceptable contraceptive regimen
- •3. Patients with clinical diagnosis of TTP
- •4. Necessitating PE (one, single PE session prior to randomisation into the study is allowed)
- •5. Subject accessible to follow-up
- •6. Obtained, signed and dated informed consent and assent (if applicable, for adolescents)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Platelet count greater or equal to 100,000/µL
- •2. Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures)
- •3. Clinical evidence of enteric infection with E. coli 0157 or related organism
- •4. Anti-phospholipid syndrome
- •5. Diagnosis of disseminated intravascular coagulation (DIC)
- •6. Pregnancy or breast-feeding
- •7. Haematopoietic stem cell or bone marrow transplantation-associated thrombotic microangiopathy
- •8. Known congenital TTP
- •9. Active bleeding or high risk of bleeding
- •10. Uncontrolled arterial hypertension
- •11. Known chronic treatment with anticoagulant treatment that can not be stopped safely, including but not limited to:
- •vitamin K antagonists
- •heparin or low molecular weight heparin (LMWH)
- •non-acetyl salicylic acid non-steroidal anti-inflammatory molecules
- •12. Severe or life threatening clinical condition other than TTP that would impair participation in the trial
- •13. Subjects with malignancies resulting in a life expectation of less than 3 months
- •14. Subjects with known or suspected bone marrow carcinosis
- •15. Subjects who cannot comply with study protocol requirements and procedures.
- •16. Known hypersensitivity to the active substance or to excipients of the study drug
- •17. Severe liver impairment, corresponding to grade 3 toxicity defined by the CTCAE scale. For the key liver parameters, this is defined as follows:
- •bilirubin > 3 x ULN (need to differentiate isolated increase in indirect
- •bilirubin due to haemolysis, this is not an exclusion parameter but
- •disease related)
- •alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 5 x ULN
- •alkaline phosphatase (AP) > 5 x ULN
- •gamma glutamyl transpeptidase (GGT) > 5 x ULN
- •18. Severe chronic renal impairment, as defined by GFR < 30 mL/min
研究者
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