2023-505638-82-00招募中3 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 14
- 主要终点
- 1. Proportion of patients with complete TMA response (cTMAr) anytime from baseline to Week 25 (after 24 weeks on treatment)
研究概览
简要总结
To evaluate the effect of crovalimab in complement inhibitor treatment-naive (Naive) patients
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Dose confirmation
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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 ALL cohorts)
- •For female patients of childbearing potential, an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (for ALL cohorts)
- •Onset of initial TMA presentation, within 28 days prior to the first dose of crovalimab (For naïve cohort only)
- •Clinical evidence of response to either eculizumab or ravulizumab, as documented by a platelet count ≥LLN, LDH ≤ULN, and stable (decrease or increase of ≤20%) or improving creatinine at two consecutive measurements at least 4 weeks apart prior to Week 1 Day 1 of crovalimab treatment. (For switch cohort only)
- •Known C5 polymorphism (e.g., Arg885) (For C5SNP cohort only)
排除标准
- •TMA associated with non-aHUS-related renal disease
- •History of a kidney disease other than aHUS, affecting renal function
- •Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome
- •Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration
- •History of Neisseria meningitidis infection within 6 months of study enrollment
- •History of malignancy within 5 years prior to screening and up to the first crovalimab administration
结局指标
主要结局
1. Proportion of patients with complete TMA response (cTMAr) anytime from baseline to Week 25 (after 24 weeks on treatment)
1. Proportion of patients with complete TMA response (cTMAr) anytime from baseline to Week 25 (after 24 weeks on treatment)
次要结局
- 11. Proportion of patients with platelet count >= LLN
- 12. Proportion of patients with normalization of LDH
- 1. Change from baseline to Week 25 in dialysis requirement status
- 2. Observed value and change from baseline to Week 25 (after 24 weeks on treatment); in estimated glomerular filtration rate (eGFR)
- 3. Proportion of patients with change from baseline to Week 25 (after 24 weeks on treatment) in chronic kidney disease (CKD) stage classified as improved, stable (no change), or worsened based on the National Kidney Foundation Chronic Kidney Disease Stage
- 4. Observed value and change from baseline to Week 25 (after 24 weeks on treatment) in hematologic parameters
- 5. Incidence and severity of adverse events
- 6. Change in targeted vital signs and clinical laboratory test results
- 7. Incidence and severity of injection site reactions, infusion related reactions, hypersensitivity, malignant hypertension, and infections
- 8. Incidence of adverse events leading to study drug discontinuation
- 9. Serum concentration of crovalimab
- 10. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab
- 13. Proportion of patients with >=25% decrease in serum creatinine from baseline
- 14. Time to complete TMA response (cTMAr)
- 15. Duration of cTMAr, among patients who achieved cTMAr
- 16. Proportion of patients with cTMAr
- 17. Proportion of patients with maintained TMA control (mTMAc) from baseline through Week 25
- 18. Incidence and severity of clinical manifestations of drug-target-drug complexes (DTDCs) in patients who switched to crovalimab treatment from either eculizumab or ravulizumab treatment
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (14)
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