New Once-Daily drug could simplify Wilson's disease treatment

NCT ID NCT07465718

Not yet recruiting Disease control Sponsor: Orphalan Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This Phase 3 trial compares a new once-daily formulation of trientine tetrahydrochloride (TETA 4HCl) to the standard drug D-penicillamine for people newly diagnosed with Wilson's disease. About 38 adults and children (ages 8 and up, weighing at least 55 lbs) will be randomly assigned to one of the two treatments for 48 weeks. The study aims to see if the new pill is safe and effective at controlling copper levels in the body.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Trientine tetrahydrochloride (TETA 4HCl)
What this could lead to
If it works, this could offer a simpler once-daily treatment option for Wilson's disease, potentially improving adherence and quality of life.
What could go wrong
This is a small Phase 3 trial with only 38 participants, so results may not apply to everyone. The new drug may not be as effective as the standard treatment, and side effects are possible.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for WILSON'S DISEASE are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Beijing YouAn Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000, China

  • Children's Hospital & Institute of Child Health

    Lahore, 54000, Pakistan

  • King Faisal Specialist Hospital and Research Center

    Riyadh, 11211, Saudi Arabia

  • PIMS Hospital

    Islamabad, 44000, Pakistan

  • Shifa International Hospital

    Islamabad, Pakistan

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhengjiang Province, 310009, China

  • University of Colorado Anschutz School of Medicine

    Denver, Colorado, 80045, United States

  • University of Michigan Medical Centre

    Ann Arbor, Michigan, 48109-2029, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

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