What the trial was testing
The CHELATE enrolled 77 patients with liver disease. The study was sponsored by Orphalan and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Trientine controlled copper levels as effectively as the standard treatment in adults with Wilson disease.
The lancet. Gastroenterology & hepatology · 2022 · NCT03539952
These findings — that all patients on trientine maintained stable disease with well-controlled copper levels — were published in the The lancet. Gastroenterology & hepatology and represent the headline result of the study.
Researchers tracked outcomes across 77 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with liver disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Trientine is FDA-approved for Wilson disease, especially for patients who cannot tolerate penicillamine. This study showed it works just as well as penicillamine for long-term maintenance. If you have Wilson disease and experience side effects with penicillamine, ask your doctor whether trientine might be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open liver disease trials
Study of GST-HG131&141 Tablets Compared With Placebo in Patients With Chronic Hepatitis B
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
Development of a FibroScan Liver Examination Using a Single Probe
This is an exploratory, international, prospective, interventional, multicenter clinical investigation that will take place in 1 Hong Kong site and 3 French sites and 309 adults patients will be included. The study objective is to assess the LSM reproducibility between the FibroScan examination performed with the Single Probe (SP) and the FibroScan examination performed with the reference probes (M and XL).