Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 (NCT04573309) | Clinical Trial Compass
CompletedPhase 2
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
United States, New Zealand, United Kingdom9 participantsStarted 2020-09-07
Plain-language summary
This exploratory study will investigate the effects of ALXN1840 on copper balance in participants with Wilson disease (WD).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Daily Copper Balance: Day 1 Through Day 8
Timeframe: Accumulation: Day 1 through Day 8 (ALXN1840 15 mg)
2
Mean Daily Copper Balance: Day 31 Through Day 35
Timeframe: Accumulation: Day 31 through Day 35 (ALXN1840 30 mg)
3
Mean Daily Copper Balance: Day 25 Through Day 28
Timeframe: Accumulation: Day 25 through Day 28 (ALXN1840 15 mg)
4
Mean Daily Copper Balance: Day 36 Through Day 39
Timeframe: Accumulation: Day 36 through Day 39 (ALXN1840 30 mg)
. 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.