A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura. - A Phase III trial with caplacizumab in patients with acquired TTP

Ablynx NV0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月23日

研究概览

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•1.Adult male or female * 18 years of age at the time of signing the informed consent form (ICF)
•2.Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g. schistocytes)
•3.Requires initiation of daily PE treatment and has received 1 PE treatment prior to randomization .

•* Platelet count *100×109/L
•* Serum creatinine level >200 *mol/L in case platelet count is > 30×109/L (to exclude possible cases of atypical Hemolytic Uremic Syndrome [aHUS])
•* Known other causes of thrombocytopenia including but not limited to:
•- Clinical evidence of enteric infection with E. coli 0157 or related organism
•- Atypical HUS
•- Hematopoietic stem cell, bone marrow or organ transplantation-associated thrombotic microangiopathy
•- Known or suspected sepsis
•- Diagnosis of disseminated intravascular coagulation
•* Congenital TTP (known at the time of study entry)
•* Pregnancy or breast-feeding
•* Clinically significant active bleeding or high risk of bleeding (excluding thrombocytopenia)
•* Known chronic treatment with anticoagulant treatment that cannot be stopped (interrupted) 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
•* Malignant arterial hypertension
•* Clinical condition other than that associated with TTP, with life expectancy < 6 months, such as end-stage malignancy
•* Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown.

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