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ABSTRACT: Purpose
To evaluate the efficacy of a novel recombinant human thyroid-stimulating hormone (ZGrhTSH) as an alternative to thyroid hormone withdrawal (THW) in dynamic assessment of DTC patients.Methods
This phase 3, open-label, multicenter trial, conducted across 27 sites in China, employed a self-controlled design to enroll patients. Eligible patients had previously undergone total or near-total thyroidectomy, with or without RAI therapy. During both the ZGrhTSH-stimulated phase and the THW phase, Dx-WBS and serum Tg measurements were performed on all participants. The study focused on the concordance of Dx-WBS results, stimulated Tg levels, and their combination in patients across the two phases. Additionally, the safety and immunogenicity profiles of ZGrhTSH were assessed
SUBMITTER: Lin Y
PROVIDER: S-EPMC12660432 | biostudies-literature | 2025 Dec
REPOSITORIES: biostudies-literature