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Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.

Study acronym: TRADITiONAL
StatusRecruiting
PhasePhase 3
SponsorOrphalan
Started
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Record History

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  1. Site details revised at 3 of 10 sites
  2. Site details revised at 1 of 10 sites
  3. Site contacts updated at 1 of 10 sites
  4. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 2026 to Sep 3, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 10 of 10 sites
  5. Trial sites expanded: 3 → 10 locations
    • Start date: Jul 2026 to Aug 2026
    v4
  6. Study sites revised (3)v3
  7. Start date: May 2026 to Jul 2026
    • Trial sites expanded: 0 → 3 locations
    • Primary and study completion pushed from Jan 2028 to Feb 2028
    v2
  8. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Orphalan
5 trials monitored
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The goal of this clinical trial is to learn if a new trientine tetrahydrochloride (TETA 4HCl) formulation administered once a day compared to d-Penicillamine (DPA) as a first line treatment for people living with Wilson's disease (WD) is effective and safe. The study is enrolling children aged 8 years and older weighing at least 55 lb (25 kg) and adults with a recent diagnosis of WD. People recently diagnosed with WD, may be eligible for the study if they have either not started copper chelating treatment (such as DPA or trientine) or have been taking zinc salts for less than 28 days. Participants will be randomly allocated (like tossing a coin) to receive either DPA or TETA 4HCL for 48 weeks. During this time period participants will have up to 12 visits for health checks and assessments including blood and urine testing. In addition, at some visits participants may be asked to complete questionnaires on treatment satisfaction, and overall well-being.
Trial Details
NCT Number NCT07465718
Lead Sponsor Orphalan
Conditions
(from sponsor)		 Wilson's Disease
Related terms Hepatolenticular Degeneration
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov