Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride (NCT07010575) | Clinical Trial Compass
CompletedPhase 2
Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
United Kingdom10 participantsStarted 2025-07-15
Plain-language summary
Decentralized study to assess patient reported treatment satisfaction comparing their current standard-of-care Wilson's Disease (WD) treatment with a new once-daily Trientine (TETA) 4HCl formulation.
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
. Willing and able to give informed consent for participation in the study.
. Proficient and fluent in English language speaker, writer and reader.
. Patients of any gender, aged 18 years or older as of signing the Informed Consent Form (ICF).
. Patients on current SOC WD maintenance treatment prescribed twice daily (or more frequently) and dose has been unchanged for at least 3-months.
. Women of childbearing potential and sexually active males must agree to adhere to a contraceptive method.
Exclusion criteria
. Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the collection or interpretation of the study results.
. Patients with severe anaemia (e.g., Haemoglobin \<10 g/dL).
. Female participants who are pregnant (including a positive pregnancy test at Screening and on Day-1) or breastfeeding.
. Any contraindications as described in the current Investigator Brochure for TETA 4HCl.
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
Assess and compare patient preference, convenience and satisfaction between current standard of care treatments for Wilson's Disease and the new TETA 4HCl formulation using patient reported outcome questionnaires.
Timeframe: From the screening assessment (-28 days to Day 1) to end of study at Week 8
2
Assess and compare patient preference, convenience and satisfaction between current standard of care treatments for Wilson's Disease and the new TETA 4HCl formulation using patient reported outcome questionnaires.
Timeframe: From the screening assessment (-28 days to Day 1) to end of study at Week 8