The effect of ALXN1840 on excretion of copper in gall as measured by copper PET/MR-scan.

Phase 1

• Conditions: Wilson's Disease; MedDRA version: 20.0Level: LLTClassification code 10047988Term: Wilson's diseaseSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2021-000102-25-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified