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临床试验/EUCTR2020-002437-15-BE
EUCTR2020-002437-15-BE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 PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)

F.Hoffmann-La Roche Ltd0 个研究点目标入组 45 人开始时间: 2021年9月3日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
45
研究概览入排标准研究者记录与标识符相似试验

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

  • •In addition to Naive and Switch patients (described above), Pretreated patients (patients who previously received treatment and then discontinued either eculizumab or ravulizumab and/or with a known C5 single nucleotide polymorphism [SNP]) will be enrolled as a separate third Cohort.
  • •For ALL (Naive, Switch, and Pretreated) Cohorts:
  • •Age >=28 days and <18 years (at the time of signing the Informed Consent Form or Assent Form)
  • •Body weight >=5 kg at screening
  • •Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years prior to initiation of crovalimab treatment. Vaccination against serotype B should be administered in accordance with current local guidelines or standard-of-care, as applicable for patients with complement deficiency
  • •For female patients of childbearing potential, an agreement to remain abstinent or use contraception, and must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab
  • •Patients with a prior kidney transplant are eligible, if they have a known history of complement-mediated aHUS prior to the kidney transplant
  • •For Naive Cohort ONLY:
  • •Onset of initial TMA presentation, as defined by a patient with all of the following laboratory findings, within 28 days prior to the first dose of crovalimab:
  • •– Platelet count < LLN, and
  • •– LDH >= 1.5 x ULN, and
  • •– Hemoglobin <= LLN (adjusted for age and sex), and
  • •– Serum creatinine >= 97.5th percentile for age. Patients who require dialysis for acute kidney injury are also eligible.
  • •NOTE: If the patient has been receiving plasma exchange/plasma infusion (PE/PI), the patient’s eligibility must be ascertained based on the above qualifying laboratory findings, obtained at onset of initial TMA presentation (prior to receiving any PE/PI) and must be within 28 days of the first crovalimab dose. The qualifying laboratory findings, even if obtained prior to screening, can be used as screening values to enroll the patient, but only if documented in the medical records.
  • •For Switch Cohort ONLY:
  • •Documented treatment with either eculizumab or ravulizumab, according to the local product label for aHUS. Eculizumab 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 Pretreated Cohort only:
  • •Onset of TMA recurrence <=28 days prior to first crovalimab administration
  • •Received and subsequently discontinued treatment with either eculizumab or ravulizumab, for a minimum of 5.5 drug half-lives
  • •For C5 SNP patients: Known C5 polymorphism AND documented treatment with either eculizumab or ravulizumab for aHUS, with poorly controlled TMA
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 35
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •For ALL (Naive, Switch, and Pretreated) Cohorts:
  • •Diagnosis of thrombotic thrombocytopenic purpura (TTP), Shiga toxin–producing Escherichia coli hemolytic uremic syndrome (STEC-HUS), clinical suspicion of pneumococcal HUS,.
  • •TMA secondary to cobalamin C defect
  • •TMA related to diacylglycerol kinase-E (DGKE) nephropathy
  • •TMA associated with non-aHUS related renal disease
  • •Positive direct Coombs test
  • •Identified drug exposure-related TMA
  • •History of bone marrow transplant or organ transplant, other than kidney transplant
  • •Chronic dialysis, within 90 days prior to first crovalimab administration, and/or end stage renal disease (ESRD)
  • •History of a kidney disease other than aHUS, affecting renal function
  • •History of Neisseria meningitidis infection within 6 months of study renrollment
  • •Known or suspected immune deficiency (e.g., history of frequent recurrent infections)
  • •Positive human immunodeficiency virus (HIV) test
  • •Life expectancy of < 4 weeks
  • •Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration
  • •Presence of fever (>=38 Degrees Celsius) within 7 days before the first drug administration
  • •Patient with active or evolving multisystem organ dysfunction or failure
  • •Immunized with a live attenuated vaccine within 1 month before first drug administration
  • •Known systemic sclerosis (scleroderma), systemic lupus erythematosus (SLE), or anti-phospholipid antibody positivity or syndrome
  • •Patients receiving chronic intravenous immunoglobulin (IVIg) within 8 weeks prior to start of screening, unless for unrelated medical condition
  • •Female patients who are pregnant, are breastfeeding, or have the intention of becoming pregnant during the study or within 46 weeks 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:
  • •First initiation of PE/PI more than 28 days prior to first crovalimab administration
  • •Last PE/PI completed less than 2 hours prior to first crovalimab administration
  • •Current or previous treatment with a complement inhibitor
  • •For Switch Cohort and Switching C5 SNP patients ONLY:
  • •Receiving PE/PI within 8 weeks of the first crovalimab administration (Switch Cohort ONLY)
  • •Positive for hepatitis B surface antigen (HBsAg) at screening
  • •Positive for hepatitis C virus (HCV) antibody at screening
  • •History of or ongoing cryoglobulinemia at screening

研究者

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