Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients. (NCT07465718)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado Anschutz School of Medicine — Denver, Colorado
Age range: 8 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- University of Colorado Anschutz School of Medicine — Denver, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- University of Michigan Medical Centre — Ann Arbor, Michigan
- Beijing YouAn Hospital, Capital Medical University — Beijing, Beijing Municipality
- Beijing Friendship Hospital,Capital Medical University — Beijing, Beijing Municipality
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhengjiang Province
- PIMS Hospital — Islamabad,
- Shifa International Hospital — Islamabad,
- Children's Hospital & Institute of Child Health — Lahore,
- King Faisal Specialist Hospital and Research Center — Riyadh,
📞 Contact the Study Coordinator
Phone: +44 (0) 7918380893
Email: clinicaloperations@orphalan.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Wilson's Disease
- A Phase I/II Study of VTX-801 in Adult Patients With Wilson's Disease — Sacramento, California
Explore by condition: All Wilson's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.