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

Conditions

• Wilson's Disease

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TETA 4HCl formulation — DRUG
  The new formulation of TETA 4HCl will be administered once a day. Each film-coated tablet is scored to enable halving, if required. Randomized participants are planned to receive TETA 4HCl for the 48-week post-randomization period.
• D-Penicillamine — DRUG
  Standard of care DPA is to be used, per the sites and treating physician's usual practice. To be administered in accordance with the product labelling and/or the institutions treatment practice guidelines. Randomised participants are planned to receive DPA for the 48-week post-randomization period.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

38 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TETA 4HCl formulation
  Participants are planned to receive TETA 4HCl for the 48-week post-randomization period.
• Active Comparator: Standard of care d-Penicillamine (DPA)
  Participants are planned to receive DPA for the 48-week post-randomization period.

Primary Outcome Measure

Absolute value of serum NCC at Week 48 assessed using the NCC-speciation assay (serum NCC-Sp) [ Time Frame: Week 48 ]

Central Contacts

• Carla Bennett, Bsc. Hons
  +44 (0) 7918380893
  [email protected]
• Omar Kamlin
  [email protected]

Locations (3)

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