Efficacy of ALXN1840 on human biliary copper excretion quantified with 64CuCl2 PET/MR-scan - ALXN1840-WD-Cu Excretion

Aarhus University Hospital0 个研究点目标入组 5 人开始时间: 2021年2月1日最近更新: 2021年4月26日

适应症

试验速览

暂无简介。

•1. A confirmed WD diagnosis based on the Leipzig criteria
•2. Current trientine or penicillamine treatment (at least for 1 year)
•3. Age above 18
•4. Fertile women must accept to apply contraception at the time of the first PET-scan until 1 month after the last PET-scan: Spiral or hormonal contraception (contraceptive pill, implantation, transdermal patch, vaginal ring or depot injection)
•5. At the day of the tracer administration, a negative pregnancy test for fertile women must be available. Pregnancy test will be performed as a urine test.
•6. At the day of the tracer administration, a signed informed consent must be available
•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 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Prior cholecystectomy or known biliary tract pathology
•2.Participation in a medical trial including a PET scan during the past year
•3.Assessed ineligibility by medical doctor on basis of blood parameters measured at inclusion, if these are abnormal.
•4.Known hypersensitivity for 64-Cu, copper in general or one of the other ingredients in the tracer formula
•5.Claustrophobia
•6.Pregnancy, breastfeeding or the desire to become pregnant before the trial is terminated

发起方

Aarhus University Hospital