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A Randomized, Open-label, Multi-center, Controlled Phase Ⅲ Study to Evaluate the Safety and Efficacy of Recombinant Human Thryoid Stimulating Hormone（rhTSH） for Adjuvant Radioiodine Ablation Therapy in Postoperative Patients With Differentiated Thyroid Cancer
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.
Details
| Lead sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 328 |
| Start date | 2021-10-06 |
| Completion | 2024-12 |
Conditions
- Differentiated Thyroid Cancer
Interventions
- rhTSH
- Radioiodine (131I)
Primary outcomes
- The rate of successful postoperative thyroid ablation — 8 months later by a rhTSH stimulated radioiodine scan
Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan
Countries
China