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New Once-Daily pill for Wilson's disease tested for patient preference

NCT ID NCT07010575

Symptom relief Sponsor: Orphalan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether people with Wilson's disease prefer a new once-daily version of the drug trientine over their usual treatment, which is taken multiple times a day. Ten adults on stable standard care tried the new formulation and reported their satisfaction and convenience. The goal was to see if a simpler dosing schedule could improve treatment experience.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Jul 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to give informed consent for participation in the study. 2. Proficient and fluent in English language speaker, writer and reader. 3. Patients of any gender, aged 18 years or older as of signing the Informed Consent Form (ICF). 4. Patients on current SOC WD maintenance treatment prescribed twice daily (or more frequently) and dose has been unchanged for at least 3-months. 5. Women of childbearing potential and sexually active males must agree to adhere to a contraceptive method. Exclusion Criteria: 1. Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the collection or interpretation of the study results. 2. Patients with severe anaemia (e.g., Haemoglobin \<10 g/dL). 3. Female participants who are pregnant (including a positive pregnancy test at Screening and on Day-1) or breastfeeding. 4. Any contraindications as described in the current Investigator Brochure for TETA 4HCl. 5. Subject receiving total daily dose of chelator as SOC greater or equal to 1200mg (trientine base or d-penicillamine). 6. In the opinion of the investigator, the patient is likely to be a non-attender or uncooperative for routine clinical visits during the study.

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Conditions

The condition(s) this trial relates to.

Wilson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Wilson's disease

Contacts and locations

Locations

  • VCTC

    Hartshorne, Derbyshire, DE11 7AQ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.