Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

Summary

This is a multicenter, randomized, open-label study with an active standard-of-care comparator (penicillamine)

Timeline

Start

2018-09-03

Primary completion

2020-08-19

Completion

2022-01-18

Publications

• Results Schilsky ML, Czlonkowska A, Zuin M, Cassiman D, Twardowschy C, Poujois A, Gondim FAA, Denk G, Cury RG, Ott P, Moore J, Ala A, D'Inca R, Couchonnal-Bedoya E, D'Hollander K, Dubois N, Kamlin COF, Weiss KH; CHELATE trial investigators. Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Dec;7(12):1092-1102. doi: 10.1016/S2468-1253(22)00270-9. Epub 2022 Sep 30.
• Ott P, Sandahl T, Ala A, Cassiman D, Couchonnal-Bedoya E, Cury RG, Czlonkowska A, Denk G, D'Inca R, de Assis Aquino Gondim F, Moore J, Poujois A, Twardowschy CA, Weiss KH, Zuin M, Kamlin COF, Schilsky ML. Evaluation of novel assays of non-ceruloplasmin copper to monitor chelation treatment in patients with Wilson disease. JHEP Rep. 2026 Jun;8(6):101822. doi: 10.1016/j.jhepr.2026.101822. Epub 2026 Mar 12.
• Ott P, Sandahl T, Ala A, Cassiman D, Couchonnal-Bedoya E, Cury RG, Czlonkowska A, Denk G, D'Inca R, de Assis Aquino Gondim F, Moore J, Poujois A, Twardowschy CA, Weiss KH, Zuin M, Kamlin COF, Schilsky ML. Non-ceruloplasmin copper and urinary copper in clinically stable Wilson disease: Alignment with recommended targets. JHEP Rep. 2024 May 6;6(8):101115. doi: 10.1016/j.jhepr.2024.101115. eCollection 2024 Aug.

Drugs

Indications