EUCTR2019-001599-12-PL进行中（未招募）1 期
A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment - SPARKLE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Male and female patients 18 years and older
- •Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations
- •Severe renal impairment such as:
- •a. Chronic kidney disease [CKD] (estimated glomerular filtrationrate [eGFR] < 30 mL/min/1.73 m2) based on medical history and previous laboratory examinations within the last 3 months prior to the Baseline Visit, OR
- •b. Acute kidney injury (AKI) with an increase in serum creatinine = 0.3 mg/dL within 48 hours or = 50% within 7 days prior to the Baseline Visit
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients with simple liver cysts only
- •Any investigational drug or device within 6 weeks prior to the Baseline Visit.
- •Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
- •Patients with moderate or severe hepatic impairment (according to Child-Pugh score B or C).
- •Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the PK subgroup.
- •Patients scheduled for surgery before last study visit.
- •Patients with encephalopathy / neurodegenerative or acute neurological disorders.
- •Patients with hemochromatosis
研究者
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