EUCTR2022-001177-31-CZ进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- 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),
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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 (ie, coma, seizures) or severe cardiac disease (cTnl >2.5 × ULN).
- •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 the Screening SARS-CoV-2 RT-PCR test.
研究者
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