Phase 3 study · Orphalan · NCT07465718
Orphalan's phase 3 trientine tetrahydrochloride study for Wilson disease
About 38 recently diagnosed people ages 8 and up are planned. Each is picked by chance to get once-daily trientine tetrahydrochloride tablets or standard d-penicillamine for 48 weeks, and everyone knows which.
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Hear when Orphalan's phase 3 trientine tetrahydrochloride study opens near you
One email when it starts enrolling or lists a new site, with the sites and how to reach the study team. Nothing else.
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Check the main requirements privately
These questions restate the study's public listing in plain words. Your answers stay on this device and are never sent. You can print a one-page summary to go over with your hepatologist.
1. Are you, or the person you care for, 8 or older?
Parents, guardians and caregivers can answer these questions for a child they care for. For anyone under the age of majority, the listing says a parent or legally authorized representative gives consent and the child agrees too.2. Do you, or the person you care for, weigh at least 25kg, about 55 pounds?
3. Has a doctor diagnosed Wilson disease with a Leipzig score of 4 or higher?
The Leipzig score is the scoring system the listing uses to define the diagnosis. Your hepatologist can tell you whether past test results reach that score.4. Have you, or the person you care for, ever been prescribed d-penicillamine or trientine for Wilson disease?
5. Have you, or the person you care for, taken prescribed zinc for Wilson disease for more than 28 days?
The listing allows up to 28 days of zinc salts before screening, and people who took zinc must have Wilson disease symptoms.6. Can you, or the person you care for, swallow tablets or capsules without help?
7. Have you, or the person you care for, needed seizure medicine in the past 6 months?
The study team also checks for these, which are easier to go over with your hepatologist:
- Acute liver failure or a high risk of it, or decompensated cirrhosis, in the study doctor's opinion
- A MELD liver score of 12 or more for ages 12 and up, or a PELD score of 10 or more for ages 8 to 11
- Hemoglobin of 9g/dL or less, an eGFR under 30mL/min/1.73m2, nephritis or nephrotic syndrome, or an alanine aminotransferase (ALT) level over 5 times the upper limit of normal
- Severe lung disease needing home nebulizer treatment or home oxygen, a clinically significant gastrointestinal bleed in the past 6 months, or neurological disease needing nasogastric tube feeding or intensive inpatient care
- Active hepatitis B or C, HIV, or any known reason a person cannot take d-penicillamine or trientine tetrahydrochloride
- A low copper diet throughout the study, and no pregnancy, nursing or planned pregnancy, with reliable birth control for participants who could have children
Sites and contact
US sites from the public ClinicalTrials.gov record, refreshed every hour. Only the study team decides who can join.
- University of Colorado Anschutz School of MedicineDenver, Colorado · Recruiting
- Yale University School of MedicineNew Haven, Connecticut · Not yet recruiting
- University of Michigan Medical CentreAnn Arbor, Michigan · Recruiting
Every site's own contact and the full eligibility list are on the official ClinicalTrials.gov listing for NCT07465718.
Questions people ask about Orphalan's phase 3 trientine tetrahydrochloride study
Is Orphalan's phase 3 trientine tetrahydrochloride study enrolling now?
ClinicalTrials.gov lists it as recruiting, as of its last update there on 2026-10-15. Only the study team can confirm whether a particular site is still taking people.
Where are the US sites for Orphalan's phase 3 trientine tetrahydrochloride study?
The listing names 3 US sites, in Colorado, Connecticut, Michigan. The full list is in the sites section of this page.
Who can join Orphalan's phase 3 trientine tetrahydrochloride study?
About 38 recently diagnosed people ages 8 and up are planned. The main listed requirements are in the pre-check on this page, starting with: ages 8 and older. Only the study team decides who can join.
How do I contact the Orphalan's phase 3 trientine tetrahydrochloride study team?
The listing names this contact: Carla Bennett, Bsc. Hons, +44 (0) 7918380893, clinicaloperations@orphalan.com. Each site may also list its own contact on ClinicalTrials.gov.
Is Trial Friend part of this study?
No. Trial Friend is independent of this study and its sponsor, Orphalan. This page restates the public listing in plain words, and nothing here is medical advice; talk with your hepatologist about whether a study is right for you.
From the public ClinicalTrials.gov record NCT07465718, last updated there 2026-10-15. Questions checked against the listing on November 10, 2026. Trial Friend is independent of this study and its sponsor, and is not a medical provider. Nothing here is medical advice; talk with your hepatologist about whether a study is right for you.