Orphalan opens China sites in Phase 3 Wilson disease trial and randomizes first participant
Orphalan said three Chinese hospitals are now recruiting for its 38-participant TRADITiONAL Phase 3 study of once-daily trientine tetrahydrochloride. Wilson disease patients aged 8 years and older can now enroll in the United States and China.
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Orphalan SA said on Nov. 12, 2026 that it has expanded the TRADITiONAL Phase 3 study of once-daily trientine tetrahydrochloride in Wilson disease into China, and that patient recruitment is now open at three Chinese hospitals, the company's release states. The study compares the investigational once-daily formulation with D-penicillamine (DPA) over 48 weeks, and the ClinicalTrials.gov record lists a planned enrollment of 38. Wilson disease patients aged 8 years and older can now enroll at sites in the United States and China, according to the company.
| Hospital | Role named by the company |
|---|---|
| Beijing Friendship Hospital, Capital Medical University | Lead site |
| The Second Affiliated Hospital, Zhejiang University School of Medicine | Site of the first randomised participant |
| Beijing You'an Hospital, Capital Medical University | Activated clinical study site |
From the company's release of November 12, 2026.
Why it matters
The trial registry record lists Orphalan as the lead sponsor of NCT07465718, a Phase 3 trial of trientine tetrahydrochloride once a day for the first line treatment of Wilson disease. The comparator is DPA, which the company calls "an established copper-chelating therapy". The record lists the Chinese locations as Beijing (two sites) and Hangzhou.
Study expansion in China
Orphalan said the expansion marks "the formal randomisation of the first participant into the study globally". The company said the first participant worldwide was randomized at The Second Affiliated Hospital of Zhejiang University School of Medicine. The company named these hospitals:
- Beijing Friendship Hospital, Capital Medical University (lead site)
- The Second Affiliated Hospital, Zhejiang University School of Medicine (site of the first randomised participant)
- Beijing You'an Hospital, Capital Medical University (activated clinical study site)
The company said enrollment is active in the United States and China and that it plans to add international study sites. Omar Kamlin, Chief Medical Officer of Orphalan, said in the release that the activation of centers in China and the randomization of the first participant represent "a significant milestone". The release is the company's own account of the milestone.
Study design and eligibility
The company describes TRADITiONAL as a global, multicentre, randomised, parallel-group, open-label Phase 3 study in symptomatic and asymptomatic Wilson disease patients aged 8 years and older. Eligible patients are either treatment-naïve or naïve to chelator therapy, and symptomatic patients treated with zinc salts for 28 days or less may be eligible, according to the release. Following approximately four weeks of screening, participants receive 48 weeks of treatment. The company said the study evaluates efficacy, safety, tolerability and patient-reported treatment satisfaction.
The record lists two arms:
- Trientine tetrahydrochloride (Experimental): trientine tetrahydrochloride once daily for the 48-week post-randomization period. Film-coated tablets are scored so they can be halved if required.
- Standard of care d-Penicillamine (DPA) (Active Comparator): DPA for the 48-week post-randomization period, per site and treating physician practice, following product labelling and/or institutional guidelines.
The record lists the eligibility as ages 8 years and older, all sexes, and no healthy volunteers.
Study outcome measures
The primary outcome listed is the absolute value of serum NCC at Week 48, assessed by the NCC-speciation assay (serum NCC-Sp). The record lists these secondary outcomes, all at Week 48:
- Serum NCC-Sp change from baseline, within specified thresholds
- 24-hour urinary copper excretion (UCE), absolute value and change from baseline, within specified thresholds
- Investigator's assessment of Wilson disease signs and symptoms using GAS for WD (Tier 1 and Tier 2 scores)
- Clinical Global Impression of Change
- Clinical stability, as determined by an Independent Adjudication Committee
Study locations and timeline
The record lists United States sites in Denver, Colorado, New Haven, Connecticut and Ann Arbor, Michigan. It lists China sites in Beijing and Hangzhou, Pakistan sites in Islamabad and Lahore, and a site in Riyadh, Saudi Arabia. The record lists the study start as 2026-09-03 (actual), with primary completion and study completion both listed as 2028-02 (estimated). It was first posted 2026-03-12, and the last update was posted 2026-10-15.
What remains uncertain
- The record lists the New Haven site, both Islamabad sites, Lahore and Riyadh as not yet recruiting (ClinicalTrials.gov record).
- The record states no dose amount for either arm (ClinicalTrials.gov record).
- The company said it plans to add international study sites (Orphalan release).
Sources
- Orphalan: Orphalan Expands Global Phase 3 TRADITiONAL Study in Wilson Disease to China Marking First Patient Randomised Worldwide (Nov. 12, 2026)
- ClinicalTrials.gov: Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients, NCT07465718
- MedlinePlus: Wilson Disease