Phase II
A Phase 2, Open-label Study to Assess Copper and Molybdenum Balance in Participants with Wilson Disease Treated with ALXN1840
- Study HIC#:2000031950
- Last Updated:01/01/0001
This exploratory study will investigate the effects of ALXN1840 on copper balance in participants with Wilson disease (WD).
The main study will be conducted in Lincoln, Nebraska. The Yale team will conduct the screening activities and, assuming you qualify for the study, will then refer you to the team in Nebraska for coordination of the rest of the study.
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Ricarda Tomlin
- Phone Number: 1-203-785-2073
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of WD by Leipzig Criteria ≥ 4.
- Able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum.
- Participants willing to adhere to copper/molybdenum-controlled diet during the study.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Decompensated cirrhosis or model for end stage liver disease score > 13.
- Modified Nazer score > 7.
- Clinically significant gastrointestinal bleed within past 3 months.
- Alanine aminotransferase > 2 × upper limit of normal.
- Hemoglobin less than lower limit of the reference range for age and sex.
- Significant medical history (current or past).
- Previous treatment with zinc within 30 days prior to the Screening Visit.
- Participants in renal failure, defined as in end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance < 30 milliliters/minute.
