2023-505089-27-00招募中3 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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 19
- 主要终点
- 1. Proportion of patients with complete TMA response (cTMAr)
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
- Non-randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ 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)
- •Adequate hepatic function, AST and ALT ≤ 3×ULN at the time of screening; no clinical signs or known laboratory/radiographic evidence consistent with cirrhosis (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)
1. Proportion of patients with complete TMA response (cTMAr)
次要结局
- 6. Incidence and severity of adverse events
- 1. Dialysis requirement status (yes/no) change
- 2. Observed value and change from baseline in estimated glomerular filtration rate (eGFR)
- 3. Proportion of patients with change from baseline in chronic kidney disease stage
- 4. Observed value and change from baseline in hematologic parameters
- 5. In adults (≥ 18 years), change from baseline in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire
- 7. Change in targeted vital signs and clinical laboratory test results
- 8. Incidence and severity of injection-site reactions, infusion-related reactions, hypersensitivity, malignant hypertension, and infections
- 9. Incidence of adverse events leading to study drug discontinuation
- 10. Serum concentrations of crovalimab
- 11. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab
- 12. Proportion of patients with platelet count ≥ LLN
- 13. Proportion of patients with normalization of LDH
- 14. Proportion of patients with ≥ 25% decrease in serum creatinine from baseline
- 15. Time to cTMAr
- 16. Duration of cTMAr
- 17. Proportion of patients with cTMAr
- 18. Proportion of patients with maintained TMA control (mTMAc)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (19)
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