The TRADITiONAL Study
For individuals diagnosed with Wilson disease, a new clinical trial may be available. Patients, caregivers, and healthcare professionals can learn more to determine whether participation may be appropriate.
This study is evaluating an investigational once-daily tablet formulation of trientine tetrahydrochloride. Trientine belongs to a class of medicines that helps remove copper from the body. The study is being conducted to evaluate whether this investigational once-daily tablet is safe and effective for people recently diagnosed with Wilson disease.
About the study
What is the goal?
The goal of this study is to find out whether the investigational once-daily trientine tetrahydrochloride tablet is as effective and well tolerated as the current standard first-line therapy,
All Wilson disease medicines require multiple daily doses or dosing around meals. This study is evaluating an investigational once-daily tablet regimen to better understand its safety, efficacy, and tolerability.
What does taking part involve?
- 48 weeks of study treatment after enrollment
- ~28 day screening period first, to confirm the diagnosis and check eligibility
- Up to 12 study visits for health checks, including blood and urine tests
- 2 groups participants are randomly assigned (like a coin toss) to receive the investigational product or standard therapy (DPA)
At some visits, study participants may also be asked to complete short questionnaires about treatment satisfaction and overall well-being. This is a Phase 3 study sponsored by Orphalan.
Who may be able to join?
Inclusion criteria:
- An adult or child, age 8 years or older, recently diagnosed with Wilson disease
- Weigh at least 55 pounds (25 kg)
- Were recently diagnosed with Wilson disease
- Have not yet started a copper-chelating medicine such as D-penicillamine (DPA) or trientine
Participants that have started zinc salts may still qualify if they have taken them for less than 28 days.
Exclusion criteria:
- Have already started DPA or trientine
- On zinc salts more than 28 days
These are general criteria. Review the study eligibility criteria to determine whether participation may be appropriate.
Study locations
The study will take place at the following US research sites, as part of a global, multicenter study.
For the most up-to-date list of study locations and their contact details, please see the study record on ClinicalTrials.gov.
Interested in learning more?
Taking part in a research study is completely voluntary.
For more information:
- Speak with a Wilson disease specialist
- For more information about Wilson disease, visit wilsondisease.org
