Trientine Tetrahydrochloride for Wilson's Disease

This study is looking at a new way to treat Wilson's disease (a genetic disorder where too much copper builds up in the body). It compares a new, once-a-day formulation of trientine tetrahydrochloride (TETA 4HCl) with the standard treatment, D-Penicillamine (DPA). The goal is to see if TETA 4HCl is safe and effective as a first treatment for people newly diagnosed with Wilson's disease. You might be able to join if you are 8 years or older, have a recent diagnosis of Wilson's disease, and haven't started copper-removing treatments (chelators) or have only been taking zinc salts for less than 28 days. The main way they'll measure success is by checking the amount of copper in your blood after 48 weeks. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 38 participants. You would be randomly assigned (like a coin toss) to receive either TETA 4HCl or DPA.
What's involved
You would receive either TETA 4HCl once a day or DPA according to standard practice for 48 weeks. There will be a 28-day screening period before treatment begins.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 48 weeks after being randomly assigned to a treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07465718

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

Not Yet Recruiting
PHASE3Ages 8+InterventionalTreatment
Orphalan
~38 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:TETA 4HCl formulationD-Penicillamine

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute value of serum NCC at Week 48 assessed using the NCC-speciation assay (serum NCC-Sp)
Measured over Week 48
Wilson's Disease
10 sites across 7 states
Pakistan3
Beijing Municipality2
Colorado1
Connecticut1
Michigan1
Zhengjiang Province1
Saudi Arabia1

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  • Absolute value of serum NCC at Week 48 assessed using the NCC-speciation assay (serum NCC-Sp)Week 48