NL-OMON53928尚未招募3 期
An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy without first-line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura - EFC16521 MAYARI
Sanofi BV0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2
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 99（—）
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
- •- 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)
- •- 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
- •- Platelet count >=100 × 109/L.
- •- Serum creatinine level >2.26 mg/dL (200 µmol/L) in case platelet count is >30
- •× 109/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 severe cardiac disease
- •- 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
- •- 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.
研究者
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