Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
Sponsor: Orphalan • ClinicalTrials.gov ID: NCT07465718
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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.
Interventions
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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.
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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.
Eligibility criteria
Conditions
Locations
- University of Colorado Anschutz School of Medicine — Denver, Colorado, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- University of Michigan Medical Centre — Ann Arbor, Michigan, United States
- Beijing YouAn Hospital, Capital Medical University — Beijing, Beijing Municipality, China
- Beijing Friendship Hospital,Capital Medical University — Beijing, Beijing Municipality, China
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhengjiang Province, China
- PIMS Hospital — Islamabad, Pakistan
- Shifa International Hospital — Islamabad, Pakistan
- Children's Hospital & Institute of Child Health — Lahore, Pakistan
- King Faisal Specialist Hospital and Research Center — Riyadh, Saudi Arabia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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