drugset / Trial / NCT04964284

Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

NCT04964284

Phase 3 Unknown 328 enrolled Suzhou Zelgen Biopharmaceuticals Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

Timeline

Start
2021-10-06
Primary completion
2024-09
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject rhTSH Protein / enzyme biologic 0.9 mg Intramuscular