Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
NCT07010575 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-04-06
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.
Conditions
- Wilson's Disease
Interventions
- DRUG
-
New TETA 4HCl Formulation
Individual patient doses will depend on the Standard of Care (SOC) therapy at study entry and guided by recommended dosing switch schedule outlined in the study protocol. The dose may subsequently be titrated based on clinical response per the investigator's judgement.
- DRUG
-
Standard of Care
Patients will be returned to their approved Wilson's Disease SOC therapy (dose and frequency) at study entry as prescribed by their treating Wilson's Disease physician.
Sponsors & Collaborators
-
Orphalan
lead INDUSTRY
Principal Investigators
-
Anna Davidsson · VCTC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-15
- Primary Completion
- 2025-12-18
- Completion
- 2025-12-18
Countries
- United Kingdom
Study Locations
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