Decentralized Study to Assess Patient Treatment Preference Comparing Their Current Standard-of-care Wilson's Disease (WD) Treatment to a New Trientine (TETA) 4HCl Formulation.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
United Kingdom
VCTC
RECRUITING
Hartshorne
Contact Information
Primary
Carla Bennett, Bsc. Hons
clinicaloperations@orphalan.com
+44 (0)7918380893
Backup
Omar Kamlin
clinicaloperations@orphalan.com
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Once Daily Administration of new TETA 4HCl followed by return to standard of care
The new formulation of TETA 4HCl will be administered once a day for 28 days. Each film-coated tablet contains 300 mg of trientine base.~Once completed patients will return to their standard of care Wilson's Disease treatment and be followed for a further 28 days.
Related Therapeutic Areas
Sponsors
Leads: Orphalan