2022-501883-17-00已完成3 期
(21196) A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 74
- 试验地点
- 18
- 主要终点
- Area under the curve (AUC) of gadoquatrane after single administration
研究概览
简要总结
To evaluate plasma PK of gadoquatrane after a single intravenous injection of 0.04 mmol Gd/kg bw in pediatric participants undergoing CE-MRI
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Gadoquatrane
- 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
- •Participants from birth to <18 years of age at the time of signing the informed consent form
- •Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement
- •Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement)
- •Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations
- •The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits
排除标准
- •Body weight <2500 g at screening and baseline
- •Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection
- •Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs
- •The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including PK and safety blood draws, without compromising any expected clinical care/procedure need
- •Acute kidney injury (i.e., acute renal failure)
- •Age-adjusted renal function is "decreased" (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum or plasma creatinine result obtained within 2 weeks prior to study intervention.
- •Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator
- •History of moderate to severe allergic-like reaction to any GBCA
- •Bronchial asthma which is considered unstable or had major therapeutical modification within last 4 weeks.
- •Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator
- •Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/AEs [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h ± 4 h follow-up
结局指标
主要结局
Area under the curve (AUC) of gadoquatrane after single administration
Area under the curve (AUC) of gadoquatrane after single administration
Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration
Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration
Apparent volume of distribution at steady state normalized to body weight (Vss/bw)
Apparent volume of distribution at steady state normalized to body weight (Vss/bw)
Simulation of plasma concentration at 20 minutes post-injection (C20)
Simulation of plasma concentration at 20 minutes post-injection (C20)
次要结局
- Number and intensity of treatment-emergent AEs (TEAEs), including number of SAEs, occurring within 24 (±4) hours post-injection or in the post-treatment period of 7 (±1) days after the day of study intervention
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (18)
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