EUCTR2020-002475-35-IT进行中（未招募）1 期
A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) - COMMUTE-a
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •For all Cohorts (all patients, in the Naïve, Switch and C5 SNP Cohorts, must meet the following criteria for study entry):
- •Age >= 12 years
- •Body weight >= 40 kg at screening
- •Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment in accordance with current local guidelines or standard of care, as applicable in patients with complement deficiency
- •For female patients of childbearing potential, an agreement to remain abstinent or use contraception
- •Patients with a prior kidney transplant are eligible if they have known history of complement-mediated aHUS prior to the kidney transplant
- •For Naive Cohort ONLY:
- •Evidence of thrombotic microangiopathy (TMA)
- •Onset of TMA 28 days prior to first crovalimab administration
- •For Switch Cohort ONLY:
- •Documented treatment with eculizumab or ravulizumab according to the local product label for aHUSEculizumab treatment received for at least 90 days. Patients switching from IV ravulizumab must have received at least two maintenance doses
- •Clinical evidence of response to either eculizumab or ravulizumab
- •For C5 SNP Cohort only:
- •Known C5 polymorphism (e.g., Arg885)
- •Documented treatment with eculizumab or ravulizumab for aHUS, with poorly controlled TMA, per investigator's assessment
- •Are the trial subjects under 18? yes
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •For all Cohorts (all patients, in the Naïve, Switch and C5 SNP Cohorts, must meet the following criteria for study entry):
- •Diagnosis of TTP, Shiga toxin-producing Escherichia coli (STEC) hemolytic uremic syndrome (HUS), Pneumococcal HUS,
- •TMA secondary to cobalamin C defect
- •TMA related to diacylglycerol kinase (DGKE) nephropathy
- •TMA associated with non-aHUS related renal disease
- •Positive direct Coombs test
- •Identified drug exposure-related TMA
- •History of organ transplant, other than kidney transplant
- •Chronic dialysis, and/or end stage renal disease
- •History of a kidney disease, other than aHUS, affecting renal function
- •History of Neisseria meningitidis infection within 6 months prior to screening and up to the first drug administration
- •Known systemic sclerosis, systemic lupus erythematosus, or anti-phospholipid antibody positivity or syndrome
- •Patients receiving chronic IV immunoglobulin (IVIg) within 8 weeks prior to start of screening, unless for unrelated medical condition
- •Female patients who are pregnant, breastfeeding, or have the intention of becoming pregnant during the study or within 6 months after the final dose of the study treatment
- •Splenectomy < 6 months prior to screening
- •Use of tranexamic acid within 7 days prior to screening
- •Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the patient, or would, in the opinion of the investigator, preclude the patient's safe participation in and completion of the study
- •For Naive Cohort ONLY:
- •Current or previous treatment with a complement inhibitor
- •Received plasma exchange/plasma infusion for 28 days or longer prior to the start of screening for aHUS
- •For Switch Cohort and C5 SNP Cohort ONLY (additional exclusion criteria for Switch patients and for patients with a C5 polymorphism):
- •Positive for hepatitis B surface antigen (HBsAg) at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago)
- •Positive for hepatitis C virus (HCV) antibody at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago). Patients who are seropositive for HCV but without detectable HCV RNA are eligible
- •History of or ongoing cryoglobulinemia at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago)
研究者
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