CTIS2024-513262-19-00招募中1 期
An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab andimmunosuppressive therapy without first-line therapeutic plasma exchange in adults with immunemediatedthrombotic thrombocytopenic purpura - EFC16521
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 71 人开始时间: 2024年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 71
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants with a clinical diagnosis of iTTP (initial or recurrent), which includes thrombocytopenia, microangiopathic hemolytic anemia (eg, presence of schistocytes in peripheral blood smear) and relatively preserved renal function. The iTTP diagnosis should be confirmed by ADAMTS13 testing within 48 hours (2 days)., -Participants with a clinical diagnosis of iTTP and a French TMA score of 1 or 2., -A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP), OR Is a woman of childbearing potential (WOCBP) and agrees to use an acceptable contraceptive method during the overall treatment period and for at least 2 months after the last study drug administration., -Male participants with female partners of childbearing potential must agree to follow the contraceptive guidance as per protocol during the overall treatment period and for at least 2 months after last study drug administration.
排除标准
- •Participants are excluded from the study if any of the following criteria apply: -Platelet count =100x10^9/L., -Clinical condition other than that associated with TTP, with life expectancy <6 months, such as end-stage malignancy, -Known chronic treatment with anticoagulants and anti-platelet drugs that cannot be stopped (interrupted) safely, including but not limited to: • vitamin K antagonists • direct-acting oral anticoagulants • heparin or low molecular weight heparin (LMWH) • non-steroidal anti-inflammatory molecules other than acetyl salicylic acid, -Participants who were previously enrolled in this clinical study (study EFC16521)., -Participants who received an investigational drug, or device, other than caplacizumab, within 30 days of anticipated IMP administration or 5 half-lives of the previous investigational drug, whichever is longer., -Positive result on COVID test., -Serum creatinine level >2.26 mg/dL (200 µmol/L) in case platelet count is > 30x10^9/L (to exclude possible cases of atypical HUS), -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 solid organ transplantation-associated thrombotic microangiopathy • Known or suspected sepsis • Diagnosis of disseminated intravascular coagulation, -Congenital TTP (known at the time of study entry), -Clinically significant active bleeding or known co-morbidities associated with high risk of bleeding (excluding thrombocytopenia), -Inherited or acquired coagulation disorders, -Malignant arterial hypertension, -Participants requiring or expected to require invasive procedures immediately (eg, stroke requiring thrombolytic therapy, those who need mechanical ventilation, etc.), -Those presenting with severe neurological or cardiac disease
研究者
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